Ampio's Phase I Study For Inhaled Ampion Advances To Completing Enrollment Of COVID-19 Patients With Respiratory Distress
Ampio Pharmaceuticals, Inc. (NYSE: AMPE) announced that its AP-014 Phase I clinical study of inhaled Ampion in COVID-19 patients is progressing to full enrollment. The Safety Monitoring Committee (SMC) confirmed that Ampion was safe and well-tolerated after reviewing initial patient data. The trial will enroll a total of 40 patients, with an emphasis on safety as the primary endpoint. Encouraging preliminary results include a reported improvement in a patient after using nebulized Ampion. The trial aims to confirm Ampion's efficacy amidst ongoing research.
- Phase I trial of inhaled Ampion advancing to full enrollment.
- Safety Monitoring Committee found no safety concerns in initial groups.
- Positive preliminary feedback from hospital staff on patient improvement.
- None.
ENGLEWOOD, Colo., Dec. 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that its AP-014 Phase I inhaled Ampion™ clinical study in COVID-19 patients is proceeding to full open enrollment following clearance by the Safety Monitoring Committee (SMC), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups. The trial can now accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment.
"The primary goal of this trial is to confirm the safety of inhaled Ampion, so we are pleased the SMC found no concerns after treatment of the first sets of patients," Michael Macaluso, President and CEO of Ampio Pharmaceuticals. "The enrollment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.
"We were also encouraged," continued Macaluso, "by a letter we received from staff at the hospital, sharing the dramatic improvement seen in a patient after using nebulized Ampion. Full confirmation of Ampion's efficacy awaits the conclusion of our clinical trial, but it is heartening to hear good news when it comes to COVID-19."
In the trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.
This trial, being conducted in the United States, will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point, and various measurements indicative of efficacy are secondary endpoints. Since inhalation is a new method for the administration of Ampion, cleared for clinical use by the FDA, each of the first three patient groups receiving inhaled Ampion were assessed by the SMC for an additional three days after the five-day treatment period. No safety concerns arose in any of these groups, and, as such, the trial was approved to complete full enrollment.
In related news, the Journal of Translational Medicine this week published a peer-reviewed paper on the method of action of Ampion, entitled "LMWF5A suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC," by G. Thomas, et al. The research provides evidence that Ampion, a low molecular weight fraction of human serum albumin (LMWF5A), reduces pro–inflammatory cytokine release by activating the immunoregulatory transcription factors PPARγ and AhR while also suppressing NF–κB and STAT1α pro–inflammatory pathways.
"This paper, in a high-impact journal, confirms that Ampion reduces inflammation through multiple pathways, unlike many other anti-inflammatory therapies that target only one," concluded Macaluso. "Inflammation is one of the body's most important survival mechanisms, so suppressing only one pathway merely forces the body to activate other pathways. Ampion targets multiple pathways simultaneously to interrupt the destructive cycle of inflammation and disease observed in many different inflammatory conditions."
About Ampio Pharmaceutical
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 2032 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 United States Private Securities Litigation Reform Act of 1995, as amended to date. 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 the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, 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, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. 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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