The FDA has asked Ampio Pharma to conduct another clinical trial for its osteoarthritis med, Ampion, setting back its BLA and sending its stock down 79% on Wednesday and another 26% in premarket trading.
While the agency accepted one of its pivotal trials, it did not consider the second to be adequate and well-controlled, Ampio said in an SEC filing on Wednesday. This was “[despite] our belief that the APC-003-C trial design was based on FDA guidance and feedback and consistent with FDA precedent for similar products … which we reiterated with the FDA multiple times,” the company said.
In its letter to Ampio, sent in July, the FDA recommended the company “perform an additional randomized trial with a concurrent control group” and that it checks in with the FDA on the trial design before starting the study.
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Littleton, Colorado-based Ampio disagrees with the FDA’s assessment—it will take up the “necessity” of an additional trial as it believes the data it has already provided is “sufficient to submit the BLA.”
The drug, Ampion, hasn’t had the easiest of journeys. It’s a low-molecular-weight fraction of human serum albumin developed to treat knee pain from osteoarthritis that had already failed two phase 3 trials before serving up positive results in December.
If approved, Ampio says, the treatment would be the first intra-articular injection to treat the signs and symptoms of severe osteoarthritis of the knee.