AMPE news
ENGLEWOOD, Colo. , June 4, 2015 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. today announced week 20 and week 24 results of the STRIDE study, a phase III clinical trial to investigate the effect of AmpionTM – a low molecular weight filtrate of an FDA approved biologic – to treat pain due to osteoarthritis (OA) of the knee. OA is the most common form of arthritis and affects more than 27 million people in the United States alone.
The STRIDE study allowed inclusion of patients in all disease stages and demographics, which resulted in 67 percent of patients with severe disease (Kellgren-Lawrence 4) and greater body mass index than seen in comparable OA trials. Analysis of the STRIDE study results at week 20 showed an effect over baseline of 59 percent in K-L3 (p less than 0.001) and 31 percent (p less than 0.001) in K-L4 patients. That reduction in pain persisted and was not materially different at week 24.
"No approved therapy has been shown to be effective in relieving OA pain for the most severely affected patients, indicating a clear medical need," said Michael Macaluso, Chief Executive Officer. "Ampio remains committed to delivering a safe, innovative medicine, as evidenced by our continued progress towards regulatory filing."
The full Ampion™ data set will be included as part of the company's Integrated Summary of Effectiveness (ISE) – a comprehensive analysis that integrates trial data used for FDA submission. The ISE for Ampion™ includes OA patient data (moderate to severe) from the SPRING, STRUT and STRIDE trials. This data will include over 700 patients using the WOMAC A (pain scale) as their primary endpoint. Results show Ampion™ to have a statistically significant improvement over saline control (p equal to 0.03), despite the aberrant saline response in the STRIDE study.
Included in the ISE are results showing improved sleep, which has metabolic benefits for blood pressure, weight and depression. No drug-related serious adverse events in any Ampion™ Study.
The company will present the data to the FDA and, once regulatory guidance is received, provide detailed information through appropriate channels such as conferences and publications. Less
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