Ampio Pharmaceuticals ($AMPE) has rallied this morning after word about its positive interim analysis from a mid-stage study of its eye treatment sent its shares upward. With the upbeat interim analysis of the trial, the company plans to head to the FDA early to hammer out the design of a Phase III study of the drug for treating a leading cause of vision loss in diabetics.
The Greenwood Village, CO-based developer's shares were up 35% as of 11:22 am ET. Its stock soared by more than 60% at times Monday morning, Reuters reported.
The stock rally comes after the company said early this morning that it is wrapping up ahead of schedule the Phase II trial of Optina, a treatment for diabetic macular edema. An interim analysis of the first half of patients enrolled in the study showed that a low dose of the drug, known generically as danazol, had beneficial effects on diabetics with the eye ailment, and there were no signs that higher doses were any better.
Ampio has been building a portfolio of so-called repurposed drugs, which the company has recycled from the ranks of previously approved treatments for treating new illnesses. Take Optina: The FDA stamped an approval on danazol in the 1970s for endometriosis, yet more recently the drug has shown that it can treat a variety of other diseases, including hereditary angioedema, fibrocystic disease of the breast and, of course, diabetic macular edema.
Companies such as Ampio aim to reduce high development costs by advancing repurposed drugs, which have an existing safety profile because they have been used to treat other ailments. That can save them the time and money typically required to gain human safety data on a new drug.
- see the Reuters report
- and Ampio's release