Ampio Pharmaceuticals Inc (NYSEAMERICAN: AMPE) is having an incredible day in the market today after providing a regulatory and clinical update. Of course, the update was a positive one, leading to excitement among investors and sending the stock on a strong run for the top. Today, we’ll talk about:
- The update;
- what we’re seeing from AMPE as a result; and
- what we’ll be watching for with regard to the stock ahead.
AMPE Announces Regulatory And Clinical Update
As mentioned above, Ampio Pharmaceuticals is flying early on in the session this morning after providing a regulatory and clinical update. The update specifically surrounded Ampion™ for the treatment of severe osteoarthritis-of-the-knee (OAK). Here’s what the company had to say:
From a regulatory perspective, AMPE said that it is moving ahead with a new clinical trial design under a Special Protocol Assessment (SPA). This action is being taken to address the FDA’s concerns over the trial design that were disclosed back in August. The company did make a point to state that they disagreed with the decision regarding the insufficiency of AP-002-C and has formally requested the FDA to reconsider.
To date, the FDA has accepted a Type C meeting proposal from AMPE that could lead to a resolution of this dispute. This is important as the meeting could lead to the acceptability of AP-003-C as the second of the two required pivotal trials that will support the filing of a Biologics License Application (BLA). The meeting is scheduled to take place before the end of this month and Ampio Pharmaceuticals made a promise to promptly report any further news received to its investors.
On the clinical side of the coin, the company provided a safety update. Of 94 patients included in the study, 8 patients, or 9% of patients enrolled discontinued. On average, those included in the trial received 4 injections with total exposure of 48 weeks. AMPE said that no serious adverse events were found. However, there were 41 Adverse Events reported. 3 of these events were likely related to the procedure, not the treatment. The remaining 38 adverse events were noted as “unrelated.” However, the company did mention that two patients reported experiencing knee pain following the injection.
From an efficacy standpoint, the injection seemed to improve pain. Pain reduction after 1 injection was 39%. After 2, 3, 4, and 5 injections, the pain reduction percentages came in at 34%, 38%, 42%, and 47% respectively. Functional improvements experienced similar results with 38%, 32%, 35%, 44%, and 47% after 1, 2, 3, 4, and 5 injections respectively.
In a statement, Mike Mascaluso, CEO at AMPE, had the following to offer:
Severe OAK Patients (KL-4) whose therapeutic options are limited (strong opioids or total knee replacement) reported a consistent/persistent, beneficial effect from each repeat injection of Ampion. The OLE study of the AP-003-C pivotal trial shows that each subsequent injection of Ampion provided a sustained, significant reduction in pain, improvement in function and 70% responder rates from patients with severe OA disease.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of Ampio Pharmaceuticals, the news proved to be overwhelmingly positive. Not only did the company report progress from a regulatory standpoint, but the clinical update was also good news. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. As is usually the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:40), AMPE is trading at $0.62 per share after a gain of $0.13 per share or 26.61% 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 the company’s continued work to bring Ampion to market as it seems like things are turning in the right direction. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!