Ampio Pharmaceuticals Inc (NYSEAMERICAN: AMPE) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced positive results from a key Phase 3 clinical trial. Below, we’ll talk about the results, what we’re seeing from the stock as a result, and what we’ll be watching for with regard to AMPE ahead.
AMPE Announces Positive Clinical Results
As mentioned above, Ampio Pharmaceuticals is having an overwhelmingly strong start to the trading session today after announcing clinical results. The results came from the Phase 3 clinical trial of AmpionTM. The treatment is designed for those with severe osteoarthritis of the knee.
In the press release, AMPE said that the Phase 3 clinical trial met the primary endpoint, with 71% of treated patients meeting the OMERACT-OARSI responder criteria. According to the announcement, responders experienced an average of 53% decrease in pain as measured by WOMAC A and a 50% improvement in function. Also, patients experienced a 45% improvement in quality of life as measured by Patient Global Assessment (PGA).
AMPE also said that the treatment met its secondary endpoints. First and foremost, treated patients achieved statistical significance in composite endpoint of pain and function from baseline in both categories at 12 weeks. This data was supported by an increase in quality of life. Also, when treated with Ampion, patients experienced a significant improvement in a composite endpoint of pain and function compared to all KL 4 saline-treated patients. Finally, AMPE said that the treatment proved to be well tolerated. In a statement, Michael Macaluso, Chairman and CEO at AMPE, had the following to offer:
“We are very pleased with the positive Phase 3 data as we believe that Ampion will address an unmet medical need, providing severely diseased patients a non-opioid option that not only reduces pain, but also improves function and quality of life in a meaningful way.
We are hopeful that Ampion will serve as a safe and effective treatment for an incurable, progressive disease that afflicts 21 million people in the U.S. and over 200 million people worldwide who suffer from osteoarthritis. We look forward to working closely with the U.S. Food and Drug Administration (FDA) as we prepare to submit our Biologics License AGreement (BLA) for Ampion.”
How The Stock Is Reacting To The News
One of the first things that we learn as investors is that the news moves the market. That’s proving to be the case today. With the strong clinical results and coming BLA with the FDA, investors are excited, sending the stock toward the top. At the moment (10:12), AMPE is trading at $2.79 per share after a gain of $1.04 per share (59.43%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on AMPE. In particular, we’re interested in following the story surrounding Ampion and excited for the BLA, which will likely come next year. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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