Positive update from Phase II trial of Optina (Ampio Pharma) for Diabetic Macular Oedema - 21-Mar-2012

An interim review of the first 50% of patients enrolled in a Phase II trial of Optina (danzol), from Ampio Pharma, for Diabetic Macular Oedema has been completed. A preliminary assessment of the primary end point (as determined by optical coherence tomography) 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. Conducted at St. Michael Hospital in Toronto Canada, the study’s main goal is to assess the efficacy and safety of two oral doses of Optina in patients with early signs of DME. These preliminary results are in keeping with the in-vitro data, which demonstrated a biphasic effect of the drug (effective in reducing vascular permeability at very low doses and cessation of these beneficial effects at the higher doses, which are used clinically for other approved indications). 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. According to detailed analysis of the study results will follow.