Market Overview

AMPIO Announces Ampion STRIDE Study Results

Share:

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that the multiple injection STRIDE study AP008 did not reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared to baseline for patients receiving Ampion™ (WOMAC A: p < 0.001). This pain reduction with Ampion™ was consistent across all sites and with our previously reported studies (SPRING and STRUT). Ampion™ is safe and well tolerated.

Ampio Pharmaceuticals Logo.
Ampio Pharmaceuticals launched the Phase III program for AmpionTM – a low molecular weight filtrate of an FDA approved biologic – to treat pain due to osteoarthritis (OA) 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. In OA, saline is known to be a partial therapeutic and not a true placebo, but 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 WOMAC A for the saline control arm ranged from 12 percent to 60 percent from site to site. This is more than twice the range we have previously seen in our studies. Historically, in larger studies, the response to saline has been reported to be in a range of 30-35 percent.

In addition, we are analyzing the demographic differences between the patient populations in the STRIDE study compared to the SPRING and STRUT studies.

Disease Severity: 68 percent of subjects in the STRIDE study had severe disease (Kellgren-Lawrence 4) versus 38 percent in the STRUT study and 23 percent in the SPRING study;
Weight: Patients in the STRIDE study were significantly heavier than patients in the STRUT study or other published trials.
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.

We will meet with the FDA to discuss our full clinical findings as soon as practical. The FDA requires a certain minimum number of patients exposed for an acute therapy. The additional patient exposure from the STRIDE study allows us to meet this requirement. We believe that the SPRING and STRUT studies could be used as "two well conducted trials" necessary for the BLA filing.

"There is ample evidence from our multiple clinical trials that AmpionTM provides significant clinical benefit to a large number of patients with osteoarthritis of the knee," said Michael Macaluso, CEO, "We are confident that AmpionTM will significantly improve the quality of life of patients suffering from OA."

Based on current projections, Ampio Pharmaceuticals has sufficient funds to continue operations through 2016, complete additional trials if necessary, manufacture AmpionTM for the BLA filing and complete the activities necessary to bring our product to market approval. The company's previously issued financial guidance for 2015 remains unchanged.

Posted-In: News FDA Press Releases

 

Related Articles (AMPE)

View Comments and Join the Discussion!
Lightning Fast
Market News Service
$199 Free 14 Day Trial

Corn Little Lower

Leerink Swann Initiates Team Health Holdings At Outperform