Category: Press Releases

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

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.

 

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.

SAN JUAN CAPISTRANO, CA and NEW YORK, NY — January 20, 2011 —Allegro Ophthalmics, LLC, announced that Barry Kuppermann, MD, PhD, will present expanded data on the Integrin Peptide Therapy phase 1 human study for the treatment of diabetic macular edema (DME), as well as a recently completed additional animal study conducted by Peter Campochiaro, MD, at The Wilmer Eye Institute at Johns Hopkins.

The presentation, “Integrin Inhibition for the Treatment of Diabetic Macular Edema,” will take place on Saturday, January 21, as part of a presentation panel from 10:45-11:45 am at the Farkas Auditorium, New York University School of Medicine in New York. In addition to presenting data demonstrating that more than 50% of patients in the phase 1 Study experienced three to five lines of improvement in best corrected visual acuity (BCVA) with corresponding improvements in OCT central macular thickness (CMT), Dr. Kuppermann will present expanded data showing that the Phase 1 study nonresponders did not experience any material loss in BCVA or increase in CMT during the study. Additionally, several patients entered the study with early proliferative diabetic retinopathy (PDR), and nearly all of these patients experienced either a regression or no progression in their disease during the study.

This open label, single dose study focused on determining the safety and initial efficacy of integrin peptide therapy. All enrolled patients suffered from advanced stage DME with or without early PDR, possessing a visual acuity of 20/100 or worse. In addition to demonstrating a three to five line improvement in BCVA for the more than 50% of trial patients, the treatment benefits lasted until the end of the study (i.e., 90 days off treatment) — significantly longer than current standard of care.

In addition, Dr. Kuppermann will be presenting new data regarding the recently completed study by Peter Campochiaro using ALG-1001 with an ischemic retinopathy treated mouse model for pre-retinal neovascularization. This study proved that three different doses of ALG-1001 exhibited statistical significance with respect to causing significant inhibition of neovascularization.

“This is exciting progress for Allegro and ALG-1001,” said Dr. Kuppermann, Professor & Chief of The Retina Service at University of California, Irvine and member, Allegro Ophthalmics’ scientific advisory board. “This is an entirely new platform for treating patients with vascular eye diseases and we are getting study results that are showing it has great potential.”

Integrin peptide therapy is an emerging new class of treatment for vascular eye diseases. By utilizing a small molecule discovered by Allegro Ophthalmics’ founders in collaboration with CalTech, ALG-1001 works earlier in the cascade than current anti-VEGF treatments by binding to multiple integrin-receptor sites and affecting multiple angiogenic pathways.

“Integrin peptide therapy is an emerging new class of treatment for vascular eye diseases based on our discovery of ALG-1001, an anti-integrin oligopeptide. Introducing a new class of treatment that works upstream with a different mechanism of action from current anti-VEGF treatment can provide additional options and benefits to patients,” said Vicken Karageozian, M.D., Co-Founder and Chief Technology Officer, Allegro Ophthalmics.

Integrin peptide therapy works by delivering a small, anti-integrin oligopeptide with a unique MOA that shuts off VEGF production directly at its source, blocking activation of VEGF receptors, inhibiting tyrosine kinase, and causing a PVD and vitreous liquefaction to increase VEGF turnover.

By contrast, therapies in the current standard of care for patients suffering from neovascular eye diseases (such as DME, Wet Age-Related Macular Degeneration and Diabetic Retinopathy) bind and inhibit vascular endothelial growth factors (VEGFs) that cause bleeding and fluid leakage into the eye.

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