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ALDERLEY PARK, UK - Redx Pharma (LSE:REDX) has announced the presentation of positive Phase 1 clinical trial results for RXC008, a potential first-in-class treatment for fibrostenotic Crohn’s disease. The findings were shared by Dr. Florian Rieder at the 20th Congress of the European Crohn’s and Colitis Organisation (ECCO) on Friday.
The trial assessed the safety, tolerability, and exposure levels of RXC008, an orally administered pan-Rho-associated coiled kinase (pan-ROCK) inhibitor. The study involved healthy participants and aimed to evaluate the drug’s impact on intestinal fibrosis, a complication of Crohn’s disease.
RXC008 was reported to be well-tolerated with no serious adverse events or treatment discontinuations. Notably, the drug demonstrated minimal systemic exposure while achieving efficacious concentrations in gastrointestinal (GI) tissue. This could represent a significant advancement in treating Crohn’s disease, as current management of fibrotic strictures is primarily surgical.
Dr. Florian Rieder highlighted the drug’s potential as a novel treatment option for an underserved patient population. Dr. Helen Timmis, Interim Chief Medical (TASE:BLWV) Officer at Redx Pharma, expressed optimism about the Phase 1 results and the upcoming Phase 2 study planned for the second half of 2025.
The Phase 1 study included single and multiple ascending dose trials, with participants receiving up to 1000mg as a single oral dose and up to 300mg daily over 14 days. No hypotension or tachycardia, common side effects of systemic pan-ROCK inhibition, were observed.
RXC008’s design allows it to be restricted to the GI tract, avoiding the cardiovascular side effects associated with systemic ROCK inhibitors. With over 1.7 million people affected by Crohn’s disease globally and a high incidence of fibrosis development, RXC008 could provide a much-needed therapeutic option.
The information presented is based on a press release statement from Redx Pharma.
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