SAN JUAN CAPISTRANO, Calif.--(BUSINESS WIRE)--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.”
“Allegro and the Helmsley T1D Program share a commitment to bringing additional treatment options to the millions of people with diabetes who are at risk of vision loss and blindness,” says Marc Kirshbaum, Chief Operating Officer, Allegro Ophthalmics. “The financial support of the Helmsley Charitable Trust makes a significant difference in advancing Luminate’s Phase 2 DME study, and we are grateful for this.”
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 vitreo-retinal 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 vitreo-retinal 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 www.allegroeye.com.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
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.