- Positive FDA response provides guidance on multiple pathways forward on paused Phase III trial in osteoarthritis of the knee (OAK)
- Phase I trial of inhaled Ampion in COVID-19 respiratory distress meets primary endpoint, achieves better reduction in all-cause mortality than in interim analysis
- IRB approval of Phase II inhalation and intravenous (IV) trial protocols clears way to begin patient enrollment
- Phase I Long-hauler COVID-19 trial awaiting IRB approval
ENGLEWOOD, CO, April 27, 2021 – Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that it had received a positive response from the U.S. Food and Drug Administration (FDA) on its plans for its AP-013 Phase III trial for the intra-articular injection of Ampion™, its novel anti-inflammatory, for patients suffering from severe osteoarthritis of the knee (OAK).
“I am pleased with the positive response we received from the FDA on our AP-013 study,” commented Michael Macaluso, President and CEO of Ampio. “The FDA’s response provides guidance and flexibility on how to maintain the Special Protocol Assessment, or SPA, while allowing the company to evaluate and consider several paths for moving the program forward. We will be further evaluating the FDA’s guidance internally and, in addition, discuss the options with potential partners. We will provide additional details on our upcoming earnings call on May 5th.”
The AP-013 study was paused in early 2020, along with over 1,000 other trials, because of the COVID-19 pandemic, and the FDA was providing Ampio with guidance on steps for moving forward and completing the trial. The AP-013 study is being conducted under a Special Protocol Assessment (SPA) which provides a documented and structured framework for communication and gaining agreement with the FDA to support a commercial Biologics Licensing Application (BLA).
As previously noted, Ampio will provide an update on its plans for this trial at its upcoming earnings call on May 5th.
The company also reported that all patients in its AP-014 Phase I trial of inhaled Ampion for COVID-19 acute respiratory distress syndrome (ARDS) had completed treatment, including a follow-up at Day 28 after treatment. The study not only met its primary endpoint of safety and tolerability, but the final data showed an even greater improvement in all-cause mortality over patients treated using Standard of Care (SOC) than reported at the time of the interim analysis. Specifically, mortality in the SOC group was 24% (interim analysis reported as 21%), while in the group treated with Ampion mortality was only 5% (interim analysis reported as 8%). (See separate release for more details.)
“These are strong results from a Phase I trial, and we are looking forward to continuing immediately with a set of double-blind placebo-controlled Phase II trials utilizing Ampion in patients adversely impacted by COVID-19, both in an inhaled form for lung inflammation and intravenously for more systemic symptoms of COVID-19,” continued Macaluso. “We have IRB approvals for both trials will commence enrolling patients in the U.S.”
Separately, the Phase I study using Ampion to address the respiratory symptoms experienced by COVID-19 “Long Haulers” is awaiting Investigational Review Board (IRB) approval and is expected to commence enrollment shortly. 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 the debilitating effects from the disease long after there is no detectable virus in their system. These “long hauler” COVID-19 symptoms are now known clinically as Post-Acute Sequelae of SARS-CoV-2, or PASC.
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.