Companies in the biotech and pharmaceuticals field are generally riskier than other companies because a single failed study could make or break the company, similar to what happened with Ampio Pharmaceuticals Inc. (NYSEMKT: AMPE).
Ampio announced Monday that its multiple injection STRIDE study AP008 did not reach its primary endpoint against the saline control. However despite this result, there was a statistically significant reduction in pain compared to baseline for patients receiving Ampion.
The company launched the Phase 3 program for Ampion to treat pain due to osteoarthritis (OA) of the knee. Each patient received three 4 ml intra-articular injections of Ampion or the saline placebo, one at baseline, the second at two weeks and the third at four weeks. In OA, saline is known to be a partial therapeutic and not a true placebo, but it has been the control used in all published OA drug trials.
In the STRIDE study, the saline control arm varied well out of a normal range, when compared to previous Ampion studies, and from the published results for other OA drugs. In the STRIDE study, the percentage change in Western Ontario McMaster Arthritis Index (WOMAC) for the saline control arm ranged from 12% to 60% from site to site. This is more than twice the range that Ampio has seen in previous studies. Historically, in larger studies, the response to saline has been reported to be in a range of 30% to 35%.
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Michael Macaluso, CEO of Ampio, said:
There is ample evidence from our multiple clinical trials that Ampion provides significant clinical benefit to a large number of patients with osteoarthritis of the knee. We are confident that Ampion will significantly improve the quality of life of patients suffering from OA.
Based on current projections, Ampio has sufficient funds to continue operations through 2016, complete additional trials if necessary, and manufacture Ampion. The company ended 2014 with cash and cash equivalents totaling $50.3 million. The company has a total market cap of $138.25 million.
Ampio also did not make any adjustments to its previous guidance.
Monday afternoon, shares of Ampio were down 65%, at $2.72 in a 52-week trading range of $2.49 to $9.01. The stock has a consensus analyst price target of $14.00.
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