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

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.

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