Redx Pharma PLC (AIM:REDX) has said it expects to have top-line clinical data from a phase IIa study of its fibrosis candidate in the first quarter of next year as it said patient recruitment was underway in five countries across Europe,
RXC007 is an oral selective Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor and is being evaluated in people with idiopathic pulmonary fibrosis (IPF) – scarring of the lungs that makes breathing difficult.
Redx is carrying out a multi-cohort, randomised, double-blind, placebo-controlled dose-ranging trial that will assess safety, tolerability, and assess for early efficacy signals over a 12-week period.
The trial also includes a 28-day dosing period sub-study to evaluate target engagement and fibrosis modification.
Regulatory and ethics approvals for both the 28-day and 12-week groups have been received in five European countries, and patient recruitment is underway at multiple study sites.
Meanwhile, US enrolment into the 28-day translational science sub-study has begun, but the 12-week cohorts are under a partial clinical hold by the US Food & Drug Administration (FDA) pending additional non-clinical data later this year.
“We anticipate topline data from both the 12-week and 28-day cohorts to be available in the first quarter of 2024,” confirmed Redx chief executive Lisa Anson in a statement.
“Our ongoing non-clinical programme will provide the data needed to support longer-term dosing in the US later this year.
“We're excited about the potential of our next-generation ROCK2 inhibitor, RXC007, to treat fibrotic conditions and address a significant unmet medical need," she added.