Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today provided an update of the ongoing Company activities required to file a Biologics License Application (BLA) for Ampion for the treatment of severe Osteoarthritis of the knee (OAK).
Michael Macaluso, Ampio’s CEO, noted that ‘During the time that AP-003-C, the second of our two required pivotal phase III clinical trials, was designed and executed, the FDA underwent a major reorganization. As a consequence, Ampio was overseen by three different review groups representing two different review offices within the Center for Biologics Evaluation Research (CBER). Currently, Ampion is being reviewed by CBER’s newly formed Office of Tissue and Advanced Therapies (OTAT).’
The company is currently focused on completing the following regulatory requirements established by the FDA
Perform two pivotal clinical trials of Ampion that CBER accepts as adequate and well-controlled studies that demonstrate the safety and efficacy of Ampion. These two pivotal trials are not required to be identical but must meet pre-determined endpoints and provide substantial replication of results.
All Ampion clinical studies must provide evidence in support of a BLA.
FDA must accept the Chemical and Manufacturing Controls (CMC) program for the investigational product.
Ampio Corporate Update
The Company is reporting the following milestones in support of the three objectives outlined above: On August 16, 2018, OTAT reaffirmed that ‘FDA considers AP-003-A to be an adequate and well-controlled clinical trial that provides evidence of the effectiveness of Ampion. AP-003-A can contribute to the substantial evidence of effectiveness necessary for the approval of a BLA.’ Over 2,000 patients now support the substantial evidence necessary for the BLA.
The AP-003-C OLE study was designed to support the safety and tolerability of repeat injections of Ampion (up to five injections) over the course of at least one year. No serious drug-related adverse events have been reported, and all patients demonstrated a sustained reduction in pain over the course of the trial.
On September 27, 2018, OTAT provided a favorable response, with no areas of dispute, in support of CMC for the Ampion BLA. Agreement was obtained ‘on the CMC data requirements for BLA and on the data presented for analytical characterization, commercial release specifications, and potency of Ampion drug product.’
The Company is continuing discussions with the FDA to determine if the pivotal AP-003-C study is the final trial required to support the Ampion BLA. Should another trial be required, the Company will move quickly to meet the FDA requirements under a Special Protocol Assessment (SPA).
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