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ARCA Biopharma Announces Completion of FDA Pre-IND Consultation Under Coronavirus Treatment Acceleration Program for AB201 as a Potential Treatment for Severe COVID-19
ARCA anticipates filing an IND for AB201 for COVID-19 in September 2020 and initiating Phase 2B clinical testing as early as Q4 2020WESTMINSTER, CO /
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"ARCA anticipates filing an IND for AB201 for COVID-19 in September 2020 and initiating Phase 2B clinical testing as early as Q4 2020WESTMINSTER, CO / ACCESSWIRE / August 12, 2020 / ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced it has completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP). The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19. With this feedback, ARCA anticipates submitting its IND application in September 2020 in preparation for initiating a Phase 2B clinical trial as early as the fourth quarter of this year.A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the FDA's guidance for clinical trials for the sponsor's new drug candidate. The FDA has created CTAP as a special emergency program for possible coronavirus therapies which is designed to use every available method to move new treatments to patients as quickly as possible, while evaluating safety and effectiveness.Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, \"Receiving the FDA's guidance is an important step in developing and executing our clinical development program for AB201. With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19. AB201's differentiated mechanism of action may also allow for use in combination with other COVID-19 therapeutics and provide a potential treatment for those patients who cannot take vaccines or for whom vaccines are not effective.\"About AB201 (rNAPc2)AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of ...