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Taysha Gene Therapies Announces Expanded Eligibility in REVEAL Phase 1/2 Adult Trial to Include Adolescent Rett Syndrome Patients
Health Canada authorized the Company’s protocol amendment that expands eligibility to include patients aged 12 and older with stage four Rett syndrome in the
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"Health Canada authorized the Company’s protocol amendment that expands eligibility to include patients aged 12 and older with stage four Rett syndrome in the REVEAL Phase 1/2 adult trial in Canada Protocol amendment broadens TSHA-102 treatment potential to both adolescent and adult patients with Rett syndrome Dosing of the third patient in the REVEAL Phase 1/2 adult trial (age 12+ protocol) and completion of cohort one (low dose) expected in the fourth quarter of 2023/first quarter of 2024 DALLAS, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that Health Canada has authorized the protocol amendment to the ongoing REVEAL Phase 1/2 adult trial evaluating TSHA-102 that expands eligibility to include patients aged 12 and older with Rett syndrome. “Following review of the initial clinical data from the first two adult patients treated with TSHA-102 and Chemistry, Manufacturing, and Controls (CMC) data, Health Canada has authorized our protocol amendment to include adolescent patients aged 12 years and older in the ongoing REVEAL Phase 1/2 adult trial,” said Sukumar Nagendran, M.D., President, and Head of R&D of Taysha. “Amending our protocol broadens the patient population who can potentially benefit from TSHA-102. We look forward to further advancing the clinical development of TSHA-102 and building on the encouraging data demonstrated in the first two adult patients treated.” Rumana Haque-Ahmed, Senior Vice President, Regulatory Affairs of Taysha, added “Health Canada’s clearance of the protocol amendment is an important milestone in our quest to develop a potentially transformative treatment for all patients and families in the Rett syndrome community. We look forward to future discussions with Health Canada and other regulatory authorities as we execute on our development plan to bring TSHA-102 to patients as safely and expeditiously as possible.” TSHA-102 is being evaluated in the REVEAL Phase 1/2 adult trial in Canada, a first-in-human, open-label, randomized, dose-escalation and dose-expansion study evaluating the safety and preliminary efficacy of TSHA-102 in females aged 12 and older with stage four...