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 firstname.lastname@example.org
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.