Saturday, June 25, 2022

Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) Breaks Out on Strong Phase 3 Data

Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) surprised everyone this week and shooting up 33% Thursday on some stellar news. This is capping a massive +200% run up the charts that started in late September.
The Osteoarthritis drug reached its Phase 3 endpoint for this biotech – primary and secondary – meeting the necessary criteria (more on that below). Responders experienced, on average a 53% decrease in pain as measured by WOMAC A and a 50% improvement in function as measured by WOMAC C and a 45% improvement in the quality of life as measured by Patient Global Assessment. This is good news for AMPE and the investors definitely seconded that notion.
“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” said Michael Macaluso, Chairman and CEO, AMPE. “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 Application (BLA) for Ampion.”
Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) is a biopharmaceutical company. The Company is focused primarily on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. The Company’s two lead product candidates in development are Ampion for osteoarthritis of the knee and Optina for diabetic macular edema. Ampion is a sub 5000 molecular weight fraction of commercial human serum albumin (HSA). Optina is a low-dose formulation of danazol. The Ampio segment consists of its biopharmaceuticals compounds and the clinical trials associated with them. The Company is primarily developing compounds that decrease inflammation by inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; activating specific phosphatase or depleting available phosphate needed for the inflammation process, and decreasing vascular permeability.
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If approved, Ampion would be the first intra-articular injection to treat the signs and symptoms of patients with severe osteoarthritis of the knee (Kellgren-Lawrence x-ray grade 4).  In order to support a label for signs and symptoms, Ampion was asked to demonstrate clinical efficacy in a composite response of pain, function and be supported by quality of life.
Ampion was well tolerated with treatment-emergent adverse events (TEAEs) comparable to those of placebo in all single-injection studies of Ampion. There were no drug-related serious TEAEs associated with the Ampion arm. The safety and tolerability profile of Ampion™ is consistent with previous studies. To date, Ampion has been given to over 900 patients with no reported drug-related serious TEAEs.
AMPE plans to present a more detailed analysis of the Phase 3 and pooled data at an upcoming scientific meeting as well as submission for publication.
Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) has earned a market cap of $153.87M with 66.04M shares out. AMPE is moving forward with its next steps and we will certainly be watching. This biotech should certainly be on your radar for the near term. Sign-up for continuing coverage on shares of $AMPE stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: We hold no position in $AMPE, either long or short, and we have not been compensated for this article.

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