Ampio Pharmaceuticals (AMPE) shares sunk Monday to their lowest level in 2.5 years after the biopharmaceutical company said its multiple-injection STRIDE study AP008 failed to reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared with baseline for patients receiving Ampion. AMPE was down 61% at $3.10 in recent trading shortly after the open. It hit an intraday low so far of $3, its lowest level since September 2012; the stock’s previous 52-week low was $3.19.
Ampio had launched the Phase III program for Ampion, a low molecular weight filtrate of a Food and Drug Administration-approved biologic, to treat pain due to osteoarthritis of the knee. Each patient received three 4ml intra-articular injections of Ampion or the saline placebo, one at baseline, the second at two weeks and the third at four weeks. The company noted in osteoarthritis, saline is known to be a partial therapeutic and not a true placebo, but has been the control used in all published osteoarthritis drug trials.
In the STRIDE study, the saline control arm varied well out of a normal range when compared with previous Ampion studies and from the published results for other osteoarthritis drugs.
“Once we have had more time to analyze the STRIDE data, we will host a conference call to present our findings and answer questions from our shareholders,” the company said, adding it will meet with the FDA “as soon as practical.”
