PYC Completes RP11 Phase 1 Trial Dosing for Cohort 2

Nov 03, 2023

PYC Therapeutics (ASX: PYC) has successfully completed dosing for the second cohort of patients in its phase 1 clinical trial for Retinitis Pigmentosa type 11 (RP11), a childhood blinding eye disease. The trial aims to evaluate the safety and tolerability of VP-001, a potential disease-modifying drug, in RP11 patients. The drug recently received Fast Track status from the US FDA. A Safety Review Committee will assess data from cohorts 1 and 2 in December to consider moving forward with dosing in the third cohort, maintaining the timeline for completion by the end of 2023.

The company may also seek approval for a fourth, higher-dose cohort in Q1 2024. PYC plans to initiate a mid/late-stage multiple-dose clinical trial in Q2 2024, with initial data across safety, tolerability, and efficacy expected in 2024. RP11 is a rare disease caused by PRPF31 gene deficiency, and VP-001 aims to restore gene expression using PYC's drug delivery technology. PYC Therapeutics is a biotechnology company focused on RNA therapies for genetic diseases, pioneering drug candidates for blinding eye diseases and other conditions.

 

 

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