Ampio Pharmaceuticals (NYSEAMERICAN:AMPE) has announced an overview and update of its clinical development activities/pipeline and released Q3 2020 financial results.
Ampio provides an update on inhaled ampion
The company hosted a webinar attended by its CEO and President Michael Macaluso, Daniel Stokely the CFO, Ms Laura Goldberg, the VP and David Bar-Or, the founder and director. During the webinar, the company offered clinical updates of its COVID-19 platform involving inhaled AP-014 and intravenous AP-016. The company also discussed the possibility of getting an Emergency Use Authorization for inhaled ampion. The webinar also discussed the differences between Ampion and other treatment alternatives for COVID-19.
Recently Ampio commenced recruitment and enrolment of patients in a Phase I randomized, multicentre, controlled study of 40 patients. The study will assess the efficacy and safety of inhaled ampion in combination with standard of care for hospitalized COVID-19 patients with respiratory distress. The company will commence dosing of patients at Penrose Hospital in Colorado and plans to expand enrolment in future to other hospitals.
COVID-19 patients will receive ampion through inhalations which will allow the drug to precisely target and reduce inflammation of lungs. They will administer ampion through a handheld nebulizer for patients with mild to moderate COVID-19 or invasive/mechanical ventilation in patients with severe COVID-19.
OAK clinical trial halted due to COVID-19
Regarding the company’s Osteoarthritis of the Knee (OAK) clinical trial, Ampio indicated its ongoing Phase III under the Special Protocol Assessment (SPA) with the FDA had been halted due to COVID-19. In April 2020, the FDA provided “FDA Guidance on Conduct of Clinical Trial of Medical Products during the COVID-19 Pandemic.” Also, in June, the agency released “Statistical Considerations for Clinical Trials During the COVID—19 Public Health Emergency.” The company harmonized the OAK Phase III study with the FDA guidance and provided a SPA revision to the FDA.
At the end of the quarter, the company had $9.4 million in cash and investments. The company posted a net loss of $3.4 million in Q3 2020.