Redx Pharma PLC - Alderley Edge, England-based clinical-stage biotechnology company focused on the treatment of cancer and fibrotic disease - Updates on its lead fibrosis candidate, RXC007, which is currently being assessed in a phase 2a study. Says regulatory and ethics approvals for the 28-day and 12-week cohorts of the study have been received in five countries. Adds recruitment is progressing at a number of study sites, but says enrolment in the US 12-week cohort has not begun due to a partial US Food & Drug Adminstration hold, pending a data readout from an ongoing non-clinical programme. The requested data is expected later this year. US enrolment in the 28-day cohort is unaffected.
Topline data from the phase 2a study is expected in the first quarter of 2024.
Chief Executive Lisa Anson says: "We are pleased to be actively recruiting our Phase 2a IPF study in both Europe and the US, putting us in a position to report topline data from both the 12-week and 28-day cohorts in Q1 2024. We expect our ongoing non-clinical programme to provide the data during 2023 to address the FDA request and support longer term dosing in the US."
Current stock price: 49.40 pence, up 0.8% in London on Thursday afternoon
12-month change: down 41%
By Heather Rydings, Alliance News senior economics reporter
Comments and questions to newsroom@alliancenews.com
Copyright 2023 Alliance News Ltd. All Rights Reserved.
