ENGLEWOOD, Colo., April 3, 2018,/PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announces the Company has retained PAREXEL® (www.parexel.com/) to assist in preparing and presenting the Biologics License Application (BLA) for Ampion™ for the treatment of osteoarthritis-of-the-knee (OAK) to the FDA.
Mr. Macaluso, Ampio’s CEO, noted that “PAREXEL is particularly suited to assist the Company in the preparation and presentation of the BLA to the FDA because their CRO Division helped design and manage the successful pivotal Phase III clinical trial. The results for which were reported on December 14, 2017, and are summarized below:
- Ampion met its primary endpoint with 71% of Ampion treated patients meeting the OMERACT-OARSI responder criteria, which exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis of the knee (p < 0.001). Responders experienced, on average a 53% decrease in pain as measured by WOMAC A and a 50% improvement in function as measured by WOMAC C and a 45% improvement in the quality of life as measured by Patient Global Assessment (PGA).
- In the secondary endpoints, Ampion treated patients achieved statistical significance in a composite endpoint of pain and function from baseline in both categories at 12 weeks (p < 0.001), which was supported by an increase in quality of life as measured by patient global assessment (PGA) (p < 0.001).
- When treated with Ampion (n=144), patients experienced significant improvement in a composite endpoint of pain and function compared to all KL 4 saline-treated patients (n=206) in Ampion single injection phase 3 clinical trials (p < 0.001).
Mr. Macaluso further noted that “two additional events of significance have occurred:
- The Open-Label Extension (OLE) study has closed enrollment (satisfying the FDA requirement for 100 patients treated with multiple injections) for the assessment of the clinical safety for long-term treatment with Ampion (up to 5 yearly injections). The product continues to demonstrate the safety and tolerability of continuous long-term use of Ampion with no drug-related Treatment Emergent Adverse Events (TEAEs) or serious TEAS reported in the OLE study.
2. Publication in the Journal of Orthopaedics of “Minimal Clinically Important Improvement Response In Patients With Severe Osteoarthritis Of The Knee: Short Report From A Survey Of Clinicians https://doi.org/10.1016/j.jor.2018.03.034, authored by Dr. Eric Stahl MD and Kristin Salottolo MPH.
This survey of assessments of “clinically meaningful reductions in pain, function and Global Assessment” by 27 KOLs most frequently selected 20% MCII in KL4 patients. Clinicians were divided on responder rate, selecting 20%, 30%, and 50% equally. Ampion significantly exceeded all these numbers in their pivotal clinical trial, as noted above.”
Mr. Macaluso continued “If approved, Ampion would be the first intra-articular injection to treat the signs and symptoms of patients with severe osteoarthritis of the knee (Kellgren-Lawrence x-ray grade 4). To support a label for signs and symptoms, Ampion was asked to demonstrate clinical efficacy in a composite response of pain, function and be supported by quality of life, all of which was demonstrated in this pivotal clinical trial.”
Regulatory Exclusivity and IP protection:
The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a “reference product” upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes, this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
About PAREXEL For over 35 years, PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies as well as an astute guide, able to simplify that journey for our client’s so safe new products can reach patients more quickly.
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™, as well as those associated with clinical trials, regulatory approvals, the ability of Ampio to enter into partnering arrangements, the Biological License Application (BLA) and decisions and changes in business conditions and similar events, 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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