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Ampio Pharmaceuticals (NYSE American: AMPE) announced the completion of enrollment for its Phase I clinical trial of Ampion™ for IV treatment of COVID-19 patients needing supplemental oxygen. Results are expected shortly from the Safety Monitoring Committee. The ongoing Phase III trial for Ampion in treating severe osteoarthritis of the knee (OAK) was paused due to COVID-19 but is set to resume with a proposal to the FDA planned for early Q4 2020. Ampio's product has the potential for significant market exclusivity upon FDA approval.
Ampio Pharmaceuticals (NYSE American: AMPE) announced updates on its COVID-19 clinical trials. The Phase I trial for intravenous Ampion treatment has completed initial safety assessments and is cleared for further patient enrollment. An independent Safety Monitoring Committee reviewed the results, confirming Ampion's safety. Additionally, the FDA requested further safety testing for nebulized Ampion, with preclinical trials showing no toxicity, and the trial protocol is under FDA review. Ampio's lead drug is positioned for 12-year market exclusivity upon FDA approval.
Ampio Pharmaceuticals (NYSE American: AMPE) is advancing its immunology-based therapies with a focus on treating COVID-19. The company has initiated a Phase 1 clinical trial to evaluate the safety and tolerability of its intravenous treatment, Ampion™, for patients requiring supplemental oxygen. This trial aims to assess Ampion's efficacy in addressing the overactive inflammatory response seen in COVID-19 patients. With significant patent protection extending to 2032 and potential FDA market exclusivity, Ampio is positioned to explore promising therapeutic targets amidst the ongoing pandemic.
Ampio Pharmaceuticals (NYSE American: AMPE) announced the publication titled Insights into pediatric multi-system inflammatory syndrome and COVID-19 on July 20, 2020. This study highlights a syndrome resembling Kawasaki Disease in children, which may be treatable with Ampion™. Dr. David Bar-Or emphasizes the potential of Ampion, alone or with IVIG, to address this condition. The company continues its evaluation of Ampion as a viable treatment option. Ampio holds a robust patent portfolio and anticipates 12-year FDA market exclusivity upon approval as a novel biologic.
Ampio Pharmaceuticals (AMPE) has received FDA clearance to initiate human trials for its IV Ampion™ treatment aimed at COVID-19 patients who require supplemental oxygen. The Phase 1 clinical trial will assess Ampion's effectiveness as an immunomodulatory anti-inflammatory agent to combat the inflammatory processes associated with COVID-19. Previous in-vitro studies suggest Ampion may be beneficial in treating acute respiratory distress syndrome (ARDS) and cytokine storms linked to the virus. The product is protected by an extensive patent portfolio and may enjoy FDA market exclusivity upon approval.