ENGLEWOOD, Colo., November 26, 2018,/PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today updates the regulatory and peer-review publication status of Ampion.
Statisticians representing Ampio and the FDA met recently to discuss the clinical pathway of Ampion™, the company’s lead drug, for the treatment of severe Osteoarthritis-of-the-knee (OAK). All KL-4 patients, from each single injection trial, were subjected to a statistical review that resulted in the FDA scheduling an additional, internal meeting that will include reviewers from the Office of Tissue and Advanced Therapies (OTAT). The review of Ampion was transferred from the Office of Blood Research and Review (OBRR) to OTAT during the most recent FDA re-organization. After reaching internal consensus, OTAT has indicated it will provide final guidance by mid- December that will determine whether the clinical trial portion of the Ampion BLA process is complete or will require an additional trial, which would be carried out under a Special Protocol Assessment (SPA).
Accumulating clinical and in-vitro evidence for the efficacy and disease-modifying properties of Ampion are summarized in a recent comprehensive review article published in Current Rheumatology Reviews entitled: “On the mechanisms of action of the low molecular weight fraction of commercial human serum albumin in osteoarthritis.” Bar-Or D, Thomas G, Rael LT, Frederick E, Hausburg M, Bar-Or R, Brody E. Current Rheumatology Review. 2018 Nov 19.
The peer-reviewed article describes inflammation and healing biochemical pathways (including functional cartilage regeneration), relevant to OA, that are affected by at least three of the well characterized chemical components present in Ampion. These pathways include the Aryl Hydrocarbon Receptor (AHR), the scavenger receptor CD-36, the cyclooxygenase 2 (COX2) and its beneficial prostaglandin products, and the mammalian Target of Rapamycin (mTORC1) protein.
The in vitro experiments show that the effects of Ampion coupled with recent and published clinical data from previous clinical trials of single and multiple injections of Ampion into OAK patients’ knees, demonstrated improvements in pain, function, and Patient Global Assessment (PGA), as well as high responder rates that could be attributed to the multiple mechanism of action (MOA) pathways summarized in this article.
Scientific Advisory Board members, David Bar-Or MD, Edward Brody MD, Ph.D. and Pablo Rubinstein MD, stated that “available in vitro and in vivo data are highly suggestive of Ampion being a safe and effective disease-modifying drug for OAK (DMOAD).”
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 the 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.
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 including the timing thereof, 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, 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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