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GEN News Highlights : May 7, 2012

ActiveSite Wins $1.3M to Complete Preclinical Development of Oral Diabetic Macular Edema Drug

National Eye Institute phase 2 SBIR grant will fund IND-enabling safety and toxicology studies.

ActiveSite Pharmaceuticals has been awarded a competitively renewed Phase II SBIR grant of up to $1.3 million by the NIH’s National Eye Institute. It will fund continued preclinical development of its lead orally administered plasma kallikrein (PK) inhibitor for the treatment of diabetic macular edema (DME). ActiveSite says it will use the funds to carry out preclinical safety and toxicology studies required to file an IND application for the start of clinical trials.

ActiveSitehas previously been awarded funding by the NIH and other sources for its DME program. “The National Eye Institute’s continuing support of ActiveSite’s research efforts to identify and develop a safe, small molecule approach to the treatment of DME has allowed this program to reach this important milestone,” remarks Sukanto Sinha, Ph.D., CEO. “This moves us closer to the goal of bringing this novel, first-in-class, patient-friendly pharmacological approach into the clinic.”

There are currently no FDA-approved drugs for DME, and, unlike ActiveSite’s PK inhibitor, drug candidates already in late-stage clinical development are delivered intravitreally, the firm notes. Preclinical studies have demonstrated that ActiveSite’s lead PK inhibitor stops diabetes-induced leakage of fluid into the retina in clinically relevant rodent models when delivered systemically.