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Benitec Biopharma Releases Third Quarter 2023 Financial Results and Provides Operational Update
9 subjects enrolled into the OPMD clinical development program HAYWARD, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC)
About this update from Benitec Biopharma Inc.
[{"type":"text","content":"9 subjects enrolled into the OPMD clinical development program\nHAYWARD, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference (\"ddRNAi\") platform, today announced financial results for its Third Fiscal Quarter ended March 31, 2023. The Company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2023 with the U.S. Securities and Exchange Commission. “We continue to screen and enroll OPMD subjects into the Natural History Study at the U.S. clinical study site, and enrollment is proceeding at a rapid pace,” said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. “With 9 subjects enrolled to date, the current pace of enrollment supports our central clinical development goals of administering BB-301 to OPMD subjects in 2H2023 and disclosing interim safety and efficacy data in 2H2023 for one or more subjects that have received BB-301.” Dr. Banks continued, “We remain focused on opening additional clinical study sites in Canada and France, pending ongoing discussions with Institutional Review Boards and regional regulators. While those discussions progress, we continue to advance the development of BB-301 in the United States and expect to receive a response from the U.S. FDA regarding the Investigational New Drug (IND) application for BB-301 in the Second Calendar Quarter of 2023.” Operational Updates The key milestones related to the development of BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD), along with other corporate updates, are outlined below: BB-301 Clinical Development Program Overview: The BB-301 clinical development program will be conducted in the United States, Canada, and France, and the primary elements of the program are summarized below: The program will comprise approximately 76 weeks of follow-up which we anticipate will consist of: The OPMD Natural History (NH) Study: 6-month pre-treatment observation periods for the evaluation of baseline disposition and natural history of OPMD-derived dysphagia (swallowing impairment) in each study participant.Dosing with BB-301: 1-day of BB-301 dosing to initiate participation in the Phase ...