Benzinga | May 10, 2021 08:45AM EDT

Ampio Pharmaceuticals Says Receives Investigational Review Board Approval For Phase I Long COVID-19 Trial (AP-018) Using Inhaled Ampion With Patients Exhibiting Prolonged Respiratory COVID-19 Symptoms

ENGLEWOOD, CO, May 10, 2021 -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, today announced that it has received Investigational Review Board (IRB) approval to commence enrollment in its AP-018 Phase I study using inhaled Ampion(tm) with patients exhibiting prolonged respiratory COVID-19 symptoms, known as long (or long-haul) COVID, or Post-Acute Sequelae of SARS-CoV-2.

"This trial is both needed and exciting in that it addresses a major current and expected ongoing unmet medical need among the estimated 3 to 10 million individuals currently suffering from long COVID," said Michael Macaluso, President and CEO of Ampio. "A significant percentage of patients who have contracted COVID-19 over the past year -- even those with mild or asymptomatic cases -- continue to suffer debilitating effects long after there is no detectable virus in their system. These symptoms stem from the out-of-control inflammatory immune response the virus triggers, something Ampion may be able to address."

The trial will be led by Principal Investigator Michael J. Barber, MD, PhD, FACC, FHRS, FAHA, who has more than 36 years of practice as a board-certified Internist, Cardiologist and Electrophysiologist and is the Director of Medical, Cardiovascular and Intravenous Nutritional Services for the Strata Integrated Wellness Spa.

In commenting on his role as Principal Investigator of the study, Dr. Michael Barber said, "Patients suffering from long COVID have a serious need for treatments, yet little research has been done so far. We look forward to exploring the anti-inflammatory effects of Ampion in patients suffering from long COVID."

The Phase 1 study, "A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms due to COVID-19 (Long-COVID)," is to evaluate the safety and efficacy of inhaled Ampion in adults with prolonged respiratory complications after COVID-19 infection. Thirty (30) participants with a confirmed, symptomatic COVID-19 diagnosis who continue to experience at least two COVID-19 respiratory symptoms will be randomized in one of two groups, active or placebo control. Both groups will be given a nebulizer to use at home for five days. Participants will be followed for 60 days after treatment.

The primary endpoint of the study is the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) from baseline to Day 28 and Day 60. Exploratory efficacy endpoints also assess the effect of inhaled Ampion compared to placebo on the clinical outcomes for participants with prolonged respiratory complications after a COVID-19 infection. Details on the study will be found on clinicaltrials.gov, once posted.