Ampio Pharmaceuticals Inc. (AMPE) announced FDA acceptance of its IND and the treatment of the first fifteen patients in its clinical trial using Ampion to treat osteoarthritis or OA of the knee.
According to the company, this randomized, placebo-controlled, double-blind trial proceeds in two parts. The company said that the study design will allow us to present two well-conducted clinical trials for a biologic license application (BLA). The first run-in portion of the trial, designated as the "Spring Study" will evaluate two doses of Ampion in 320 adult patients suffering from moderate to severe OA of the knee.
This run-in portion will determine the optimal dosage of Ampion that will be used in the second portion of the pivotal trial. The number of patients required in the second part of the study will be determined based on an analysis of the first part, the company said.
Ampion is a non-steroidal anti-inflammatory biologic that has the potential to be used in a broad array of inflammatory conditions and autoimmune diseases. One of the active ingredients of Ampion is aspartyl-alanyl diketopiperazine, referred to as DA-DKP, which is derived from the two amino acids from the terminal end of human albumin and appears to have a significant role in the homeostasis of inflammation.
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