E Ampio Fails To Meet Primary Endpoint In Osteoarthritis Trial

Shares of Ampio Pharmaceuticals (AMPE) dropped 66% after the company reported that it failed to meet the primary endpoint in a phase 3 clinical trial. This phase 3 clinical trial was known as the STRIDE trial and recruited up to 320 patients who either took 4ml of intra-articular injections of Ampion or the saline placebo. The company attributes this study failure to the fact that the saline placebo performed much better than in the other studies. The other studies that Ampio ran for osteoarthritis are known as "SPRING" AND "STRUT". 

The STRIDE study saw placebo results ranging from 12% to 60% which is unusually high. Ampio states that the other clinical trials that test a saline placebo achieve between 30% to 35%. Although the company failed to meet the primary endpoint in the STRIDE trial it believes that it can file a Biologics Licence Application -- BLA -- to the FDA using the other two phase 3 clinical trials mentioned above. 

Ampio states that it now has sufficient capital to run the company all the way through 2016 and run additional trials if needed. It will all depend on the meeting with the FDA, but it's possible the FDA could allow Ampio to file the BLA just using the other two phase 3 trials. Osteoarthritis occurs when cartilage on the ends of the bones wear down over time. This causes the patients a lot of pain which gradually worsens as the patient gets older. There are no current cures for osteoarthritis but Ampio still believes its injection drug could help alleviate the pain these patients experience in their daily lives. 

Disclosure: no position any stocks mentioned

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