Flim-flam alert: Ampio Pharmaceuticals (AMPE) wants us to believe that patient enrollment in its ongoing study of Optina in diabetic macular edema is being cut short because doctors say the drug is working.
Really? The hip waders I normally wear for protection from biotech bullshit aren't tall enough to wade through Ampio's current press release. I need a full haz-mat suit. Let's unpack the truth about what Ampio is really up to with Optina. Carefully.
1. The Optina study was supposed to complete enrollment of 450 diabetic macular edema patients in the first quarter. That's what Ampio told investors in its 10-K filing on February. At that time, the study had enrolled "over 300" patients and top-line results were expected in the third quarter. Enrollment in the Optina study reached 346 patients, as of Ampio's first-quarter 2014 10-Q filing on May 7.
Today, Ampio says enrollment in the Optina study is being stopped at "over 355 patients" and top-line results will be ready in the fourth quarter. Ampio's Chief Medical Officer Vaughan Clift:
Since DME is a very serious and progressive condition that often leads to blindness, the company believes it is in the patient's best interest to analyze the data as soon as possible to confirm any observed benefits. By reducing the patient sample size, we can expect data by Q4, 2014.
Vaughan, I'm confused. Not only has Ampio missed its own enrollment guidance, but with fewer patients actually participating in the Optina study, the analysis and release of top-line results will take longer?
2. Ampio's explanation for chopping patient enrollment is even stranger. Here's Vaughan, again: