OCT 16, 2013
The U.S. Food and Drug Administration has approved an investigational new drug application to begin two Phase II clinical studies of ALG-1001, a first-in-class integrin peptide therapy, for patients with wet AMD or symptomatic vitreomacular traction.
Integrins play a key role in cell signaling and regulating cellular shape, motility and the cell cycle. Allegro’s ALG-1001 turns off the production of aberrant blood vessels, reducing the leakage of aberrant blood vessels, and inhibiting the growth of aberrant blood vessels.
“We are extremely pleased with the FDA’s approval, which validates our preclinical data, multiple Phase I study results, and Phase II clinical study design,” said Vicken Karageozian, MD, co-founder and chief technical officer of Allegro. “In just over three years, we’ve rapidly and methodically gone from compound discovery to Phase II clinical trials. We are optimistic that this drug will continue to show efficacy and provide meaningful therapeutic benefit to patients with vascular eye diseases, such as wet AMD and VMT.”
These Phase II studies will be the fifth and sixth studies of ALG-1001. The other studies are two Phase I studies that have already been completed–one monotherapy study in each of diabetic macular edema and wet AMD. Two Phase Ib/IIa studies are in progress.