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Nebulizer trial continues to move forward as progress

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TJG Member Level  Wednesday, 11/25/20 09:19:16 AM
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Nebulizer trial continues to move forward as progress is positive from the 3 safety trials.

Ampio Updates Regulatory and Clinical Trial Events
9:15 AM ET 11/25/20 | Dow Jones


ENGLEWOOD, Colo., Nov. 25, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today the following updates:

-- Patients experiencing respiratory distress due to COVID-19: In the Phase

I inhaled Ampion(TM) clinical trial (AP-014), the third of three initial

safety groups of patients have completed their five days of treatment and

three days of follow up for Safety Monitoring Committee (SMC) review (as

inhalation is a new delivery method of Ampion cleared for clinical use by

the FDA). Once the SMC provides confirmation regarding no safety concerns

for this third group, the trial will accelerate to complete the remaining

thirty-four patients at the speed of recruitment with additional hospital

groups added as required to support enrollment.

-- Patients with severe osteoarthritis of the knee (OAK): The amendment to

the OAK Phase III clinical trial (AP-013), that harmonizes the FDA

agreement on the Special Protocol Assessment (SPA) with FDA guidance for

clinical trials on hold due to COVID-19, has been received by the FDA.

The FDA notified the Company that a formal response will be provided by

the end of this year.


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