Taysha Gene Therapies Announces Updates to TSHA-102 Clinical Program in Rett Syndrome
DALLAS, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (“Taysha” or “the Company”), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced updates to its TSHA-102 program in clinical evaluation for the treatment of Rett syndrome. The Independent Data Monitoring Committee (IDMC) approved the Company’s request to proceed to dose escalation in the REVEAL Phase 1/2 adolescent and adult trial, enabling earlier advancement to the high dose cohort of 1x1015 total vg. The IDMC also approved the dosing of the second patient in cohort one (low dose) of 5.7x1014 total vg in the REVEAL Phase 1/2 pediatric trial. The decisions follow IDMC review of available clinical data from the patients dosed with TSHA-102. The Company also announced the expansion of its ongoing REVEAL Phase 1/2 adolescent and adult trial in Canada into the United States (U.S.) following submission of the adolescent and adult trial protocol to the U.S. Food and Drug Administration (FDA).
- The decisions follow IDMC review of available clinical data from the patients dosed with TSHA-102.
- The trial is taking place in Canada and the U.S. TSHA-102 is administered as a single lumbar intrathecal injection.
- Update on available clinical data from completed cohort one of 5.7x1014 total vg expected in the first quarter of 2024.
- Initial safety and efficacy data from cohort two (high dose, n=3) of 1x1015 total vg expected in the second half of 2024.