Clinical Status of Ampion and COVID-19 – Inhaled Ampion (Nebulizer)
Administering Ampion to patients by inhalation allows the drug to directly target and attenuate inflammation in the lungs.
Directly administering Ampion to patients by inhalation allows the drug to directly target and attenuate inflammation in the lungs.
Preliminary results from the AP-014 Phase I trial of inhaled Ampion indicate:
- Ampion demonstrated an improvement in all-cause mortality in COVID-19 patients compared to standard of care (SOC). A lower all-cause mortality rate of 8% is observed for the Ampion treatment group, compared to 21% in standard of care alone.
- Patients who received Ampion required less hospitalization time. The average hospital length of stay was 7 days for the Ampion group compared to 11 days for standard of care patients.
- Patients who received Ampion required less oxygen than standard of care alone, and 86% of Ampion patients were stable or had improvement compared to 75% of SOC patients.
- More patients who received Ampion were stable or had improvement on a scale of clinical improvement compared to standard of care alone. By day 5, 86% of patients who received Ampion were stable or had improvement compared to 75% of standard of care patients. This trend in improvement with Ampion treatment is noted as early as day 2 and continues to day 5.
- Adverse events were the same between Ampion and standard of care, and no drug-related serious adverse events have been reported.
This data was presented to the FDA for consideration as a potential emergency use authorization treatment for COVID-19 patients, and the FDA recommended moving to a Phase II randomized, double-blind, placebo-controlled clinical trial. The FDA indicated that this trial design may allow for an effective and efficient review of data results and support the safety and statistical significance and effectiveness of Ampion treatment, which are necessary for the FDA to objectively review the known and potential benefits of Ampion against any potential risks to be considered for emergency use authorization.
The protocol of this Phase II clinical trials for inhaled Ampion in treatment of COVID-19 respiratory distress is being finalized, with the trial expected to start in Q2 2021.
Clinical Status of Ampion and Post-Acute Sequelae of SARS-CoV-2 (PASC) COVID-19 “Long Hauler” Symptoms
Inhaled Ampion may be useful in helping those who still suffer the after-effects of COVID-19 long after the virus is gone.
The complications from COVID-19 stem not from the virus but from the out-of-control inflammatory immune response it triggers, which remains a problem long after the infection is over. Inhaled Ampion may provide a significant therapeutic benefit for those patients plagued by the “long haul COVID-19 symptoms” of PASC.
The trial design will deal specifically with respiratory distress-related symptoms and will involve an “at home” treatment, where patients will receive a nebulizer and a five-day supply of inhaled Ampion. The trial protocol is being finalized, with commencement of the study expected by mid-Q2 2021.
Ampion regulates the immune response
Ampion uses the power of the immune response and is in development to treat osteoarthritis, respiratory illness due to COVID-19, and a wide range of other debilitating and life-threatening inflammatory conditions.