ENGLEWOOD, Colo., May 10, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: 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™ 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.
Relevant Recent History
On April 27, 2021, the company reported that all patients in its AP-014 Phase I trial of inhaled Ampion for COVID-19 have completed treatment, including a follow-up at Day 28 after completion of treatment. The study not only met its primary endpoint of safety and tolerability, but final data showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) for COVID-19 respiratory distress. Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).
Forward Looking Statements
Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.