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Benitec Biopharma Releases Full Year 2023 Financial Results and Provides Operational Update
Received FDA Clearance of the Investigational New Drug (IND) application for BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy (OPMD)-Related
About this update from Benitec Biopharma Inc.
[{"type":"text","content":"Received FDA Clearance of the Investigational New Drug (IND) application for BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy (OPMD)-Related Dysphagia 15 subjects enrolled in the OPMD Natural History Study, with multiple subjects entering the eligibility period this year for entry into the BB-301 Phase 1b/2a Clinical Treatment Study Successful Closing of a $30.9 M Public Offering HAYWARD, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-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 Fiscal Year ended June 30, 2023. The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2023, with the U.S. Securities and Exchange Commission. “The pace of enrollment into the OPMD Natural History Study continues to exceed our expectations and, with the receipt of FDA clearance for the BB-301 IND application this year, we have made tremendous progress towards the initiation of the clinical evaluation of BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy-related Dysphagia. ” said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. “The Principal Investigator and the clinical team at the U.S. clinical trial site are now preparing to dose the first subject with BB-301 this year, and the strong support that we have received from investors positions the Benitec team and our clinical collaborators well to generate critical safety and efficacy data for BB-301 over the coming months.” Operational Updates The key milestones related to the development of BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD)-related Dysphagia, along with other corporate updates, are outlined below: BB-301 Clinical Development Program Overview: The BB-301 Phase 1b/2a clinical development program will be conducted in the United States and Canada, 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 OPM...