(Reuters) - Ampio Pharmaceuticals Inc AMPE.O said a mid-stage trial of its experimental drug to treat retinal swelling in diabetic patients was ended ahead of schedule based on positive interim data, sending its shares up 64 percent.
The company’s drug Optina is being tested to treat diabetic macular edema — the most prevalent cause of moderate vision loss in patients with diabetes.
Ampio, which tests drugs that are already approved to find treatments for new indications, said it plans to meet the U.S. Food and Drug Administration to decide the design of a late-stage trial, under section 505(b)2 regulation for repurposed drugs.
A 505(b)(2) application permits a company to obtain the FDA’s approval by relying, in part, on the agency’s findings for a previously approved drug, and thus reduces the time and development cost on the drug.
In a regulatory filing last year, Ampio had said it expected to launch the drug in about three years in the United States.
Optina is an oral ultra-low dose of danazol, which was approved by the FDA in the 1970s for endometriosis — a condition where cells from the uterus lining grow on other organs.
More recently, danazol was approved for a rare genetic disorder, hereditary angioedema, Ampio said.
Ampio’s strategy for repurposed drug reduces the risk of product failure due to adverse toxicology, leads to modest investments during development, and may achieve more rapid marketing approval, according to the company.
The company’s most advanced drug, Zertane, another repurposed drug, had shown promise in a late-stage trial in Europe to treat premature ejaculation.
The company’s shares were up 37 percent at $3.67 in morning trade on the Nasdaq on Monday, after touching a two-month high of $4.40 in early trading.
Reporting by Anand Basu in Bangalore; Editing by Roshni Menon and Gopakumar Warrier