Allegro Ophthalmics Awarded $2 Million Grant From Helmsley Charitable Trust

Grant will advance clinical studies of Luminate® for the treatment of diabetic macular edema

SAN JUAN CAPISTRANO, CA — February 3, 2015 — Allegro Ophthalmics, LLC, today announced that it has been awarded a $2 million grant from the Type 1 Diabetes (T1D) Program of The Leona M. and Harry B. Helmsley Charitable Trust. This is the second grant from the Helmsley Charitable Trust to Allegro, and will support Allegro’s recently commenced Phase 2 study of Luminate® (ALG-1001) in patients with diabetic macular edema (DME).

DME is the leading cause of blindness in the working age population with 4.2 million American diabetics over the age of 40 having some form of diabetic retinopathy1-2, and the prevalence of DME approaching 30 percent in adults with diabetes for 20 years or more3. In clinical studies to date, Luminate has been shown to stop and reverse the effects of DME, including inflammation, vascular leakage, and neovascularization, while also significantly reducing the burden of intravitreal injections for patients.

This Phase 2 DME study, which began in October, is evaluating the safety and efficacy of intravitreal injections of Luminate compared to the current standard of care for patients with DME. Total planned enrollment for the six-month randomized, double-masked, multi-center trial is 150 patients.

“One of our Program’s core goals is to identify and support research that helps develop new therapies for people living with T1D,” says Eliot Brenner, Director of the Helmsley Charitable Trust’s T1D Program. “By funding research toward the development of Allegro’s lead molecule Luminate, we hope to eventually offer people with T1D who are legally blind or at risk of blindness the opportunity to regain and maintain functional vision, significantly improving their quality of life.”

The $2 million grant from the Helmsley T1D Program comes just three weeks after Allegro announced that Hanmi Pharmaceutical made a $20 million strategic investment in Allegro, and Hanmi licensed Luminate for Korea and China in exchange for additional economic terms.

Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation, and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (anti-angiogenesis and vitreolysis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional nonprofits and other mission-aligned organizations in health, select place-based initiatives, and education and human services. Since 2008, when the Trust began its active grantmaking, it has committed more than $1 billion. The Helmsley Type 1 Diabetes Program is the largest private foundation funder of T1D-related research, treatment and support services in the nation. For more information, visit www.helmsleytrust.org.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema and wet age-related macular degeneration. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

# # #

References:
1.  2014 National Diabetes Statistics Report. Centers for Disease Control. Accessed September 24, 2014 at http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
2.  Statistics About Diabetes. American Diabetes Association. http://www.diabetes.org/diabetes-basics/statistics/. Accessed November 18, 2014.
3.  Klein R, Klein BE, Moss SE, et al. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology 1984;91:1464-74.

Allegro Ophthalmics Announces $20 Million Strategic Investment From Hanmi Pharmaceutical

Companies also enter into licensing agreements for Allegro’s Luminate® in The Republic of Korea and China

SAN JUAN CAPISTRANO, CA and SEOUL, KOREA — January 13, 2015 — Allegro Ophthalmics, LLC, and Hanmi Pharmaceutical Co., Ltd. today announced that they have entered into a license agreement for Luminate® (ALG-1001), Allegro’s integrin peptide therapy that is currently in multiple Phase 2 studies in the United States for the treatment of vitreoretinal conditions, in The Republic of Korea and the People’s Republic of China. Hanmi Pharmaceutical also will be making a strategic investment in Allegro that will advance and accelerate the global development program for Luminate.

Under the terms of the agreements, Hanmi Pharmaceutical is obtaining a license from Allegro for Luminate as an intraocular injection for vitreoretinal diseases, including diabetic macular edema (DME), wet age-related macular degeneration (wet AMD), and vitreomacular traction (VMT), in The Republic of Korea and China. Hanmi Pharmaceutical has agreed to pay Allegro upfront license fees, sales milestone payments, and running royalties as a percentage of net sales.

In addition to license rights for Korea and China, Hanmi Pharmaceutical will be making a $20 million strategic investment in Allegro. The closing of the transaction is subject to customary conditions, expected to be satisfied by January 16, 2015.

“Hanmi Pharmaceutical is dedicated to bringing products to market that improve health and quality of life,” says Dr. Lee Gwan Sun, President and Chief Executive Officer, Hanmi Pharmaceutical Co., Ltd. “We are pleased to be both a partner and an investor in Allegro Ophthalmics. Luminate has shown great promise in clinical studies, and we anticipate that it soon will help the millions of patients with DME, AMD, and VMT in China and Korea regain and maintain functional vision, significantly improving their quality of life.”

Allegro’s advisors in connection with this transaction were Summit Pharmaceuticals International, a subsidiary of Sumitomo Corporation, and Aquilo Partners.

Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation, and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (anti-angiogenesis and vitreolysis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Hanmi Pharmaceutical Co., Ltd.
Hanmi Pharmaceutical Co., Ltd. is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products. The Company is fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 16% of its sales in R&D and has over 20 programs in clinical development in three main areas: 1) novel long-acting biologics based on the Company’s LAPSCOVERY™ platform that aim to shift the treatment paradigm of diabetes and obesity with weekly insulin, weekly to monthly GLP-1, and their combinations (Quantum Project); 2) novel targeted agents against cancer and autoimmune disorders; and 3) fixed-dose combination programs. The Company has collaboration with global partners on various co-development and business opportunities.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema and wet age-related macular degeneration. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.

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Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

Allegro Ophthalmics Begins Phase 2 Clinical Trial Of Luminate® (Alg-1001) For The Treatment Of Diabetic Macular Edema

CHICAGO, IL — October 16, 2014 — Allegro Ophthalmics, LLC, dedicated to establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases, today announced that it is enrolling patients in a Phase 2 trial that will evaluate the safety and efficacy of Luminate®, previously known as ALG-1001, in patients with diabetic macular edema (DME).

This Phase 2 study is a randomized, controlled, double-masked, multi-center, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of Luminate® compared to the current standard of care for patients with DME. Patients will be randomized to one of five treatment groups that include three Luminate® groups (1.0 mg, 2.0 mg, or 3.0 mg), a bevacizumab (Genentech) group, and a focal laser photocoagulation group. All study subjects will return for examinations every four weeks for six months. Total planned enrollment for the trial is 150 patients.

“I’m pleased to be participating in this important study which has the potential to benefit the millions of diabetics who are at risk of losing their vision,” says David Boyer, M.D., Clinical Professor of Ophthalmology at USC/Keck School of Medicine and member of Allegro’s Scientific Advisory Board. “There is a significant need to find better treatment options that reduce the number of intravitreal injections, while helping a larger patient population. In clinical studies to date, Luminate® has been shown to be effective as monotherapy treatment to meaningfully reduce the burden of intravitreal injections, while also providing a clinical benefit for those patients who either don’t respond to anti-VEGF therapy or plateau with less than excellent vision.

“This Phase 2 clinical study design follows the prospective analysis of the Phase 1 DME study, which demonstrated strong safety and efficacy in monotherapy treatment with Luminate®,” says Vicken Karageozian, M.D., Chief Technical Officer, Allegro Ophthalmics, LLC. “In the Phase 1 study, eight of 15 end-stage DME patients treated with Luminate® experienced a three to five line improvement in visual acuity with a corresponding improvement in macular anatomy as measured three months off treatment.”

Luminate®, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation, and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (anti-angiogenesis and vitreolysis), Luminate® has been shown to be effective at regressing and inhibiting new blood vessel formation, as well as reducing vascular leakage to maintain and restore vision. Luminate® is an investigational drug not approved by the FDA.

About Allegro Ophthalmics, LLC

With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate®, is currently in Phase 2 studies and has been shown to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema and wet age-related macular degeneration. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.

###

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

Third party trademarks used herein are trademarks of their respective owners.

Allegro Ophthalmics Data to Be Presented at Two Ophthalmic Meetings: The Ophthalmology Innovation Summit (OIS) and at the American Academy of Ophthalmology (AAO) Annual Meeting

Ophthalmology Innovation Summit

WHO:  Vicken Karageozian, M.D., Co-Founder and Chief Technical Officer, Allegro Ophthalmics, will present “Allegro Ophthalmics: Accelerated Innovation, Needed Intervention” at the 5th annual Ophthalmology Innovation Summit (OIS).

WHAT:  Dr. Karageozian will share insights into Allegro’s unique approach to accelerating medical research and commercialization of a new class of therapeutic drugs for vascular and vitreoretinal eye diseases, and will discuss ALG-1001 Integrin Peptide Therapy, including findings to date from human clinical studies in DME and Wet AMD.

WHEN:  Thursday, November 14, 2013, 10:38-10:46 AM

WHERE:  Sheraton New Orleans

 

2013 American Academy of Ophthalmology (AAO) Meeting

WHO:  David Boyer, M.D., Founder, Retina-Vitreous Associates Medical Group, will present “Integrin Peptide Therapy: The First Human Wet AMD Experience” at the 2013 American Academy of Ophthalmology (AAO) meeting.

WHAT:  Dr. Boyer will present findings to date from human clinical studies of ALG-1001 Integrin Peptide Therapy in Wet AMD.

WHEN:  Tuesday, November 19, 2013, 10:12-10:19 AM

WHERE:  Ernest N. Morial Convention Center, New Orleans, Room 271-273

 

ABOUT ALLEGRO OPHTHALMICS, LLC:         

With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC is establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic macular edema and vitreomacular traction, which together affect more than six million people in the US.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for these leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision.  For more information, visit stg.allegroeye.com.

 

Allegro Ophthalmics Announces Commencement of First Human Subject Study with ALG-1001 to Treat Vitreomacular Traction

Study to Further Establish Safety and Efficacy of Integrin Peptide Therapy in Additional Indications

SAN JUAN CAPISTRANO, CA — November 4, 2013 — Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, today announced the commencement of a Phase II study of ALG-1001 in patients with vitreomacular traction (VMT).

“Current options for treating VMT are limited for the majority of patients,” said David Boyer, M.D., Clinical Professor of Ophthalmology at USC/Keck School of Medicine and member of Allegro’s Scientific Advisory Board. “While this is the first human study using ALG-1001 to treat VMT, the success of ALG-1001 in achieving total resolution of posterior vitreous detachment (PVD) in earlier studies gives us great optimism for the current study in VMT.”

“We are excited about the initiation of this Phase II clinical study with ALG-1001 for a third indication,” said Vicken Karageozian, M.D., Co-Founder and Chief Technical Officer, Allegro Ophthalmics. “Following study results from other indications, along with allowance from the FDA to proceed with Phase II studies, we are confident that this study will continue to affirm the safety and efficacy of ALG-1001, and are hopeful that ALG-1001 will provide meaningful therapeutic benefit to patients with VMT.”

The study is a placebo-controlled, randomized, double-masked, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of ALG-1001 in patients with VMT.  Patients are currently being enrolled at multiple sites outside the United States, with the primary efficacy endpoint of release of VMT being determined by optical coherence tomography (OCT) images read by Duke Reading Center.  Secondary endpoints include the observation of non-surgical closure of full thickness macular holes, BCVA improvement over baseline, and forgone need for pars plana vitrectomy.

 

About Integrin Peptide Therapy and its Role in Treating Vascular Eye Diseases

ALG-1001 is a first in class Integrin Peptide Therapy targeting integrins, which play a key role in cell signaling and regulating cellular shape, motility, and the cell cycle.  ALG-1001 approaches multiple indications by collectively turning off the production, reducing the leakage, and inhibiting the growth of aberrant blood vessels. In addition to its anti-angiogenic effects, ALG-1001 targets the key integrin receptor site at the vitreoretinal interface to release the cellular adhesion between the vitreous and the retina.  Accordingly, inducing this separation has the potential to resolve VMT. ALG-1001 is an investigational drug not approved by the FDA.

About Allegro Ophthalmics, LLC

With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC is establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic macular edema and vitreomacular traction, which together affect more than six million people in the US.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for these leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision.  For more information, visit stg.allegroeye.com.

Allegro Ophthalmics and The Helmsley Charitable Trust to Present at Partnering For Cures

November 4, 2013 Partnering for Cures presentation

SAN JUAN CAPISTRANO, CA — October 31, 2013 — Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, and The Leona M. and Harry B. Helmsley Charitable Trust will co-present at the fifth annual Partnering for Cures meeting taking place November 3-5, 2013 in New York City. Convened by FasterCures, the Washington, D.C.-based center of the Milken Institute, Partnering for Cures will bring together leaders across all medical research sectors with the express purpose of making collaboration happen.

As part of the 2013 Innovator Presentations, Allegro and the Helmsley Charitable Trust will share insights into their collaborative partnership approach to accelerating medical research and commercialization of a new class of therapeutic drugs for vascular and retinal eye diseases, including wet age-related macular degeneration (Wet AMD), diabetic macular edema (DME) and vitreomacular traction (VMT). Leveraging Allegro’s innovative approach to drug development and the Helmsley Charitable Trust’s dedication to improving the lives of people living with type 1 diabetes (T1D), they will jointly address how the Helmsley Charitable Trust’s commitment to “venture philanthropy” has significantly advanced the progress of making new treatment options available to doctors and patients.

“The goal of the research portfolio of the T1D program is to identify and develop new ways to treat and prevent T1D,” said Gina Agiostratidou, Ph.D., Senior Program Officer, the Helmsley Charitable Trust. “To achieve this goal, we strive to identify and support promising early-stage research opportunities that have a clear pathway to development and, ultimately, availability for people with T1D. We decided to support the development of Integrin Peptide Therapy, expecting to offer T1D patients who are legally blind or at risk of blindness the opportunity to regain and maintain functional vision, significantly improving their quality of life.”

Vicken Karageozian, M.D., Co-Founder & CTO, Allegro Ophthalmics, and Gina Agiostratidou, Ph.D., Senior Program Officer, the Helmsley Charitable Trust will present “A Faster Way Forward: Allegro’s Innovative Approach to The Science & Business of Drug Development” on Monday, November 4th from 11:15-11:40 am at the Grand Hyatt, New York City.

Partnering for Cures is convened by FasterCures, the Milken Institute’s Center for Accelerating Medical Solutions, a nonprofit think tank and catalyst for action that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. To learn more about Partnering for Cures, visit www.partneringforcures.org.

About the Helmsley Charitable Trust

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting effective organizations in a variety of selected areas. Since 2008, when the Trust began its active grantmaking, it has committed more than $900 million. The Helmsley Type 1 Diabetes Program is the largest private funder of T1D-related research, treatment and support programs. For more information, please visit www.helmsleytrust.org.

About Allegro Ophthalmics, LLC

With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC is establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic macular edema, and vitreomacular traction, which together affect more than six million people in the US. By quickly, safely and cost-effectively bringing to market new and improved treatment options for these leading causes of blindness, Allegro hopes to offer patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.

 

Allegro Ophthalmics Receives Fda Ind Approval For Phase Ii Clinical Studies With First In Class Integrin Peptide Therapy Alg-1001

SAN JUAN CAPISTRANO, CA — October 9, 2013 — Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to begin two Phase II clinical studies of ALG-1001. These Phase II clinical trials will be conducted in patients with wet age-related macular degeneration (wet AMD) and in patients with symptomatic vitreomacular traction (VMT).

“We are extremely pleased with the FDA’s approval, which validates our preclinical data, multiple Phase I study results, and Phase II clinical study design,” said Vicken Karageozian, M.D., Co-Founder and Chief Technical Officer, Allegro Ophthalmics. “In just over three years, we’ve rapidly and methodically gone from compound discovery to Phase II clinical trials. We are optimistic that this drug will continue to show efficacy and provide meaningful therapeutic benefit to patients with vascular eye diseases such as wet AMD and VMT.”

These Phase II studies will be the fifth and sixth studies of ALG-1001. Completed already are two Phase I studies – one monotherapy study in each of diabetic macular edema (DME) and wet AMD. Additionally, two Phase Ib/IIa studies are in progress, with one being a combination study in DME. To date, all data from human studies, as well as studies in animals, show integrin peptide therapy to be safe, well-tolerated and efficacious, including the fact that the benefit of monotherapy is holding at least three months off-treatment in both wet AMD and DME patients.

About Integrin Peptide Therapy and its Role in Treating Vascular Eye Diseases

ALG-1001 is a first in class integrin peptide therapy targeting integrins, which play a key role in cell signaling and regulating cellular shape, motility, and the cell cycle. ALG-1001 approaches multiple indications by collectively turning off the production of aberrant blood vessels, reducing the leakage of aberrant blood vessels, and inhibiting the growth of aberrant blood vessels. ALG-1001 is an investigational drug not approved by the FDA

For more information, please contact Allegro at info@stg.allegroeye.com

About Allegro Ophthalmics, LLC

With more than 100 years of combined experience in vision science and medicine, the leadership team at Allegro Ophthalmics, LLC is establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic retinopathy and diabetic macular edema, which together affect nearly six million Americans. Allegro Ophthalmics seeks to prevent vision loss and combat blindness, potentially offering millions an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.

 

Allegro Ophthalmics Co-Founder And Cto To Present At The Retinal Innovation Forum At The American Society Of Retina Specialists (Asrs) Annual Meeting

WHO: Vicken Karageozian, M.D., Co-Founder and Chief Technology Officer, Allegro Ophthalmics, will present “Integrin Peptide Therapy: A Novel Approach to Neovascular Eye Diseases” at the Retinal Innovation Forum being held during the 31st Annual Meeting of the American Society of Retina Specialists (ASRS).

WHAT: Dr. Karageozian will present an overview of Allegro and Integrin Peptide Therapy. The presentation will explain the potential benefits to patients and physicians from this novel approach to neovascular eye diseases, and will include the company’s findings to date from human clinical studies in DME and wet AMD.
Dr. Karageozian will also briefly discuss plans for future studies. A discussion and Q&A session will follow. The ASRS Retinal Innovation Forum will be moderated by Mark Humayun, M.D., Ph.D., and Peter Kaiser, M.D.

WHEN: Monday, August 26, 2013 – 3:01-3:11 PM

WHERE:
Sheraton Centre Toronto, Grand Ballroom (lower concourse)
123 Queen St. W, Toronto, Canada

ABOUT ALLEGRO OPHTHALMICS, LLC:
With more than 100 years of combined experience in vision science and medicine, the leadership team at Allegro Ophthalmics, LLC, is establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic retinopathy and diabetic macular edema, which together affect nearly six million Americans. Allegro Ophthalmics seeks to prevent vision loss and combat blindness, potentially offering millions an improved quality of life sustained by self-sufficient, functional vision.

MEDIA CONTACT:
Michele Gray
917.449.9250
michele.gray93@gmail.com

Allegro Ophthalmics And Senju Pharmaceutical Announce Collaboration In Japan To Develop Integrin Peptide Therapy As First In-Class Treatment Of Vascular Eye Diseases

SAN JUAN CAPISTRANO, CA and OSAKA, JAPAN — May 2, 2013 — Allegro Ophthalmics, LLC and Senju Pharmaceutical Co., Ltd. today announced that they have entered into a collaboration and license agreement to develop and market Allegro’s integrin peptide therapy in Japan. With this collaboration, Allegro and Senju aim to improve the quality of life for patients worldwide who continue to be at risk of blindness from vascular eye diseases by establishing integrin peptide therapy as the first-in-class treatment targeting integrin with an oligopeptide.

Under the terms of the agreement, Senju will acquire the rights to co-develop and market Allegro’s integrin peptide therapy in Japan as an intravitreal injection for vascular eye diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). In exchange for these rights, Senju has agreed to pay Allegro an eight-digit upfront license fee, additional development and sales milestone fees, and a percentage royalty on net sales.

Senju had a similarly positive outlook on the relationship. “The announcement of this partnership with Allegro further evidences Senju’s commitment to its position as a leader in ophthalmology in Japan,” said Shuhei Yoshida, Executive Vice President of Senju Pharmaceutical. “We believe that Allegro’s integrin peptide therapy shows great promise as a first-in-class treatment for Wet AMD, DME, and other vascular eye indications, and we are eager to begin the process for regulatory approval in Japan.”

Summit Pharmaceuticals International, a subsidiary of Sumitomo Corporation, served as advisor to Allegro in connection with this transaction.

Allegro recently announced that it completed enrollment of a Phase Ib/IIa study in Wet AMD patients as stand-alone therapy, and commencement of a Phase Ib/IIa in combination with anti-VEGF therapy. These two human studies are in addition to a previous Phase I study in end-stage DME patients. All data from human studies, as well as studies in animals, show integrin peptide therapy to be safe, well-tolerated and efficacious, including the fact that the benefit of mono-therapy is holding at least three months off-treatment in both Wet AMD and DME patients.

About Integrin Peptide Therapy
Integrin peptide therapy, a novel approach to treating vascular eye diseases, utilizes an oligopeptide discovered by Allegro’s founders in collaboration with Caltech. Integrin peptide therapy uniquely approaches multiple indications by collectively turning off the production of aberrant blood vessels, reducing the leakage of aberrant blood vessels, and inhibiting the growth of aberrant blood vessels. This novel approach has the potential to be both an effective stand-alone treatment as well as complementary to existing standard of care due to its unique mechanism of action. ALG-1001 is an investigational drug not approved by the FDA.

For more information, please contact Allegro at info@stg.allegroeye.com

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in vision science and medicine, the leadership team at Allegro Ophthalmics, LLC is establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic retinopathy and diabetic macular edema, which together affect nearly six million Americans. Allegro Ophthalmics seeks to prevent vision loss and combat blindness, potentially offering millions an improved quality of life sustained by self-sufficient, functional vision.

About Senju Pharmaceutical Co., Ltd.
Established in 1947 and headquartered in Osaka, Japan, Senju Pharmaceutical Co., Ltd., is a company that develops, manufactures, and commercializes a variety of innovative products on a global basis, specializing in ophthalmic preparations.

 

Allegro Ophthalmics Announces Completed Enrollment Of Wet Age-Related Macular Degeneration Study With Results To Be Presented At Arvo; Commencement Of Phase Ib/Iia Combination Therapy Study In Patients With Diabetic Macular Edema

Studies to Further Demonstrate The Safety and Efficacy of ALG-1001

SAN JUAN CAPISTRANO, CA- February 28, 2013 — Allegro Ophthalmics, LLC, today announced that it has completed enrollment of its Phase Ib/IIa study in wet age-related macular degeneration (wet AMD) in addition to commencing its second diabetic macular edema (DME). This second DME study is masked and will observe the additional clinical benefit of therapy with ALG-1001 (Integrin Peptide Therapy) in combination with bevacizumab (Avastin) versus bevacizumab alone.

The Wet AMD Study is a dose-ranging, monotherapy study with a primary endpoint of safety and a secondary endpoint of improvement in both best corrected visual acuity (BCVA) and OCT central macular thickness (CMT). Dr. Peter Kaiser will present the results of this study in a paper presentation at The Association for Research in Vision and Ophthalmology Annual Meeting on May 6, 2013 at 3:15 pm in Room 618-620.

The objective of the recently commenced DME Study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in combination with bevacizumab versus bevacizumab alone in patients with baseline DME that has not been resolved by repeated intravitreal anti-VEGF treatments. Based on results from earlier studies of end-stage DME subjects receiving ALG-1001 monotherapy, the study expects to find both reduced CMT and improved BCVA in subjects with unresolved baseline DME as a result of the combination therapy.

According to the DME Study design, 30 subjects are being divided into three groups. Two groups will receive four monthly intravitreal injections of Avastin plus ALG-1001 (at two different doses of ALG-1001) . The third group will receive four monthly intravitreal injections of Avastin and a sham injection. After the four monthly injections, the subjects will be observed for 30 days off-treatment for a total 120 days of observation.

ALG-1001 is a small molecule and a crucial agent in Integrin Peptide Therapy, a newly developed approach to treating vascular eye diseases. By utilizing a small molecule discovered by Allegro Ophthalmics’ founders in collaboration with The California Institute of Technology, Integrin Peptide Therapy uniquely approaches these indications by collectively turning off the production of aberrant blood vessels, reduces the leakage of aberrant blood vessels, and inhibits the growth of aberrant blood vessels. This novel approach has the potential to be both an effective stand-alone treatment as well as complementary to existing standard of care due to its unique mechanism of action. ALG-1001 is an investigational drug not approved by the FDA.

“The results of both of these studies could advance the potential of a paradigm shift in how we treat wet AMD and DME patients at risk for blindness,” said Vicken Karageozian, M.D., Co-Founder and Chief Technology Officer, Allegro Ophthalmics. “While the current standard of care continues to benefit many patients, we need additional treatment options, as well as more effective treatments that will allow patients living with vascular eye diseases to experience and maintain excellent vision.”

Funding for both studies has been made possible by a grant to The Wilmer Eye Institute at Johns Hopkins University from the Leona M. and Harry B. Helmsley Charitable Trust and a Series A investment round led by private individuals, including industry pioneers.

For more information, please contact Allegro at info@stg.allegroeye.com

About Allegro Ophthalmics, LLC

With more than 100 years of combined experience in vision science and medicine, the leadership team at Allegro Ophthalmics, LLC is establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of wet age-related macular degeneration, diabetic retinopathy and diabetic macular edema, which together affect nearly six million Americans. Allegro Ophthalmics seeks to prevent vision loss and combat blindness, potentially offering millions an improved quality of life sustained by self-sufficient, functional vision.