Ampio updates on Phase 1 study with inhaled Ampion in COVID-19

 

• Ampio (AMPE +0.2%) provides following update on clinical trials.
• Phase I trial of inhaled Ampion (AP-014), the third of three initial safety groups of patients have completed five days of treatment and three days of follow up for Safety Monitoring Committee review, as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA.
• If SMC provides confirmation regarding no safety concerns for this third group, the trial will complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment.
• On another front, it submited its proposal to the FDA concerning the evaluation of data in its Phase 3 trial evaluating Ampion in patients with severe osteoarthritis of the knee. Enrollment was suspended in March due to pandemic disruptions. The FDA notified the Company that a formal response will be provided by the end of this year.
• https://seekingalpha.com/news/3639424-ampio-updates-on-phase-1-study-inhaled-ampion-in-covidminus-19-patients