Ampio Pharmaceuticals Details Early Positive Results for Inhaled Ampion in COVID-19 Respiratory Distress

ENGLEWOOD, Colo., March 16, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, recently revealed preliminary positive results in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19. The Company also outlined its progress toward initiating a Phase I clinical trial using inhaled Ampion for treating those suffering lingering respiratory effects after COVID-19 infection, the so-called COVID-19 "long haulers," as well as its continued research focusing on the use of Ampion in kidney and pediatric diseases.

"We shared these promising results with the FDA in our recent request to expand that trial. The FDA's response recommended that we forego our planned unblinded expansion of the current trial and move directly to a randomized, double-blinded, placebo-controlled Phase II study of inhaled Ampion in COVID-19," said Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals. "It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy."

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.

In commenting on the preliminary positive results in the AP-014 Phase I clinical trial of inhaled Ampion, Dr. David Cornutt, MD, Chairman, Department of Emergency Medicine, Regional West Health Services, and a Medical Monitor on the study, said, "The scientific findings we have reviewed thus far are fascinating and very encouraging. While we are still looking at preliminary data from a small sample size, the safety signals look strong, and I look forward to moving into the efficacy phases to come."

Initiating trial in "long hauler" COVID-19

Ampio also provided details on its forthcoming Phase I clinical trial utilizing inhaled Ampion with patients exhibiting "long hauler" COVID-19 symptoms, now known clinically as Post-Acute Sequelae of SARS-CoV-2, or PASC. A significant percentage of the millions of people who have contracted COVID-19 over the past year – even those with mild or asymptomatic cases – continue to suffer effects from the disease long after there is no detectable virus in their system.

"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. We believe that inhaled Ampion could provide a significant therapeutic benefit for those patients plagued by PASC ("long haul symptoms")," continued Macaluso. "And, because Ampion is a platform biologic, what we learn in our upcoming trial could be applicable to a significant number of diseases displaying similar inflammatory-type characteristics, not just COVID-19."

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 currently being finalized, with commencement of the study expected by mid-Q2 2021.

Update on research into kidney and pediatric diseases

In collaboration with physician scientists at Vanderbilt University, Ampio is studying the effects of Ampion on inflammation in kidney function, as most kidney disorders involve inflammation. The preclinical research is being done in vitro on renal endothelial cells as well as on proximal tubular epithelial cells of the kidney, all cells involved in the pathophysiology of kidney inflammation.

"The results so far are promising," commented David Bar-Or, MD, Director and Founder of Ampio Pharmaceuticals, "as Ampion's method of action aligns both theoretically and is confirmed by initial in vitro experiments on those cells."

Ampio is also conducting research into the potential use of Ampion in treating post-Fontan protein-losing enteropathy in conjunction with clinicians and scientists at a major children's hospital based in Philadelphia. The Fontan procedure is a cardiac surgery performed on children born with a single chamber in their heart. Essentially, the procedure involves separating the venous from the arterial blood. Some of these children develop a post-procedure condition termed protein-losing enteropathy, which can be so severe that it necessitates a heart transplant.

"The cause of this condition is unclear and involves several theories," continued Dr. Bar-Or. "One theory involves inflammation, and we are studying this angle by performing complex in silico work on available genomics, micro-RNA, and other data sets to determine the potential molecular pathways involved. We are also undertaking in vitro experiments on lymphatic endothelial cells permeability, intestinal epithelial cells and others to demonstrate the potential beneficial effect of Ampion in this condition. This may lead to a treatment option for this dreadful condition affecting young children."

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, 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.

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SOURCE Ampio Pharmaceuticals, Inc.