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.
