Redx, a clinical-stage biotech company, is trialing RXC007, a wholly owned rho associated coiled-coil containing protein kinase 2 (ROCK2) selective inhibitor as a potential treatment for patients with idiopathic pulmonary fibrosis (IPF).
The phase 2a study is a 12-week multi-cohort, randomized, double-blind, placebo-controlled dose ranging study to assess early signals of efficacy as well as the safety and tolerability of RXC007 in IPF patients.
Both treatment-naïve patients and patients already on approved IPF therapy will be included in the study.
Key endpoints for the study will be safety and pharmacokinetic profile, changes from baseline in lung function of forced vital capacity and carbon monoxide diffusion coefficient, and changes from baseline in Quantative Lung Fibrosis Score (QLFS), airway volume and resistance on high resolution computerized tomography scan.
In the study, three dose escalation cohorts of 16 patients will be assigned a dosing period of three months, with patients potentially continuing for longer if they are seen to be tolerating their assigned treatment and there are no signs of disease progression.
Redx said a translational science sub-study will start in parallel to evaluate target engagement and disease interaction. Endpoints for this sub-study will include changes from baseline in blood biomarkers, proteins and genes from broncho-alveolar lavage (BAL) fluid, BAL-fluid cells and bronchial epithelial cells. It is anticipated that headline data from the phase 2a study will be available in the second half of next year (2023).
Lisa Anson, chief executive officer, at Redx Pharma said: “We are extremely pleased to commence this Phase 2a trial for RXC007 in IPF, a truly devastating, rapidly progressing and ultimately deadly disease, where there are few treatment options.
“ROCK2 is a biologically-validated target shown preclinically to reduce fibrosis, the key pathology of IPF. The encouraging preclinical and translational data for RXC007 have given us confidence to progress into a Phase 2 program with IPF as the lead indication.
“RXC007 will be the second wholly-owned Redx program to enter Phase 2 clinical studies, reflecting our strong progress as a Company. It is one of five compounds to come from the Redx discovery engine that are currently at the clinical development stage, a testament to the strength of our world-class medicinal chemistry expertise and drug discovery capabilities.”
Philip Molyneaux, the chief investigator for the RXC007 trial in the U.K., added: “IPF is a chronic disease with significant unmet medical need and limited therapeutic treatment options.
“ROCK, a known master switch in the fibrotic signaling pathway, is a promising target, which is heavily upregulated in IPF patients but has historically been very difficult to selectively inhibit.
“RXC007 phase 1 data showed an excellent safety and pharmacokinetic profile in both the single ascending dose and multiple dose phase, and I look forward to supporting this phase 2 trial.”