Drug maker Ampio Pharmaceuticals Inc. (NASDAQ: AMPE) reported this morning that clinical trials of the company’s Optina treatment for a type of macular disease have been successful:
A preliminary assessment, of the primary end point (OCT) indicates a beneficial and consistent effect with the ultra-low dose of Optina™ at 4 and 12 weeks of treatment and no apparent benefit at the high dose. These preliminary results are in keeping with the in-vitro data …
Based on these positive and encouraging results and the potential of lack of efficacy at the higher doses, both doses being present in this study, Ampio decided to conclude this study ahead of schedule and to proceed with the preparation of a consultation package for the FDA that includes the basic science and clinical results for discussion of the design of a pivotal trial in the US under the 505(b)2 regulation for repurposed drugs.
Ampio’s shares are trading up nearly 40% at $3.74 in a 52-week range of $2.57-$9.27