Ampion for osteoarthritis of the knee. Company noted August 7, 2018 that further trials required before filing BLA. Company said on November 26, 2018 that final guidance will be provided
Ampion for osteoarthritis of the knee. Company noted August 7, 2018 that further trials required before filing BLA. Company said on November 26, 2018 that final guidance will be provided mid-December 2018.
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.
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