Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it has completed the treatment phase of the Ampion-in-Knee (AIK) trial.
The AIK trial conducted in Australia included 60 patients with moderate to severe osteoarthritis of the knee. Results of this trial will be analyzed and reported for the tolerability of Ampion in humans and for its effects on pain and knee function associated with this condition.
"We are extremely pleased to have completed the treatment phase of this first trial of Ampion in humans as anticipated," stated Don Wingerter, Ampio CEO. "The company expects to release a summary of data analysis from this study in the coming weeks."
About the Ampion-in-Knee Trial
The AIK trial was conducted in patients diagnosed with moderately-severe to severe osteoarthritis of the knee. The 60 patients were enrolled in a 3 arm randomized double blind trial designed to establish tolerability and efficacy of Ampion.
In the three arms of the trial, patients were injected in the knee with:
1) Steroid, lidocaine, and saline,
2) Steroid, lidocaine, and Ampion, and
3) Steroid, saline, and Ampion.
Steroids, which typically do not have an onset of action until after the 72 hour clinical evaluation phase of this trial, were injected at the same time as the study medication in all arms. The efficacy endpoints for Ampion were pain perception as measured by the WOMAC pain scale and joint movement as measured by a goniometer. These endpoints were monitored at 6, 24, and 72 hours after administration of the study drugs.
Ampion, a molecule protected by a composition of matter and use patents, is naturally produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations. Because HSA and blood derived products are currently managed by the Center for Biologics Evaluation and Research division of the FDA, Ampio believes this product will be classified as a biologic.
Ampion is a non-steroidal anti inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so that it has the potential to be used in a broad array of inflammatory conditions which impact millions of patients.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
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 use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
SOURCE Ampio Pharmaceuticals, Inc.