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Taysha Gene Therapies Announces Second Patient Dosed with TSHA-102 in the REVEAL Phase 1/2 Adult Trial for the Treatment of Rett Syndrome
Available clinical data from the two adult patients dosed with TSHA-102 in the first cohort (low dose) to be discussed during upcoming quarterly earnings call
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"Available clinical data from the two adult patients dosed with TSHA-102 in the first cohort (low dose) to be discussed during upcoming quarterly earnings call following Independent Data Monitoring Committee (IDMC) review Dosing of third adult patient and completion of enrollment in the low-dose cohort expected in the fourth quarter of 2023 Dosing of first pediatric Rett syndrome patient expected in the first quarter of 2024 DALLAS, Sept. 26, 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 the second Rett syndrome patient has been dosed with TSHA-102 in the REVEAL Phase 1/2 adult trial in Canada. “Dosing the second adult patient in the REVEAL Phase 1/2 adult trial in Canada marks important progress in the ongoing clinical evaluation of TSHA-102 for Rett syndrome,” said Sukumar Nagendran, M.D., President, and Head of R&D of Taysha. “The enthusiasm for a potential disease-modifying therapy among the Rett syndrome community is encouraging, and we remain focused on further evaluating the therapeutic potential of TSHA-102 in adults and expanding the clinical evaluation to pediatric patients with this devastating disease. We look forward to reporting initial clinical data on the second adult patient and providing an update on the first adult patient in the low-dose cohort at our quarterly earnings conference call in mid-November, following the pre-specified IDMC review.” 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 adult females with Rett syndrome due to MECP2 loss-of-function mutation. TSHA-102 is administered as a single lumbar intrathecal injection. Dose escalation will evaluate two dose levels of TSHA-102 sequentially. The maximum tolerated dose (MTD) or maximum administered dose (MAD) established will then be administered during dose expansion. Enrollment in the low-dose cohort is expected to be complete in the fourth quarter of 2023 with the dosing of the third patient. The REVEAL adult trial is being conducted at CHU Sainte-Justine, the ...