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ALDERLEY PARK, UK - Redx Pharma Limited, a clinical-stage biotechnology company, has reported positive Phase 1 trial results for RXC008, a drug candidate targeting fibrostenotic Crohn’s disease. The trial findings, presented at Digestive Disease Week® 2025 in San Diego, indicated that RXC008 was well tolerated with minimal systemic exposure, paving the way for a Phase 2 study.
RXC008, a pan-Rho-associated coiled-coil kinase (pan-ROCK) inhibitor, is designed to remain within the gastrointestinal tract, reducing the risk of systemic side effects such as hypotension or tachycardia, which are common with other pan-ROCK inhibitors. The Phase 1 study involved both single ascending dose (SAD) and multiple ascending dose (MAD) trials, with doses ranging from 10mg to 1000mg for SAD and up to 300mg for MAD over 14 days.
The trial demonstrated no serious adverse events or treatment discontinuations. Moreover, the drug showed promising intestinal tissue exposure and target engagement, with efficacious concentrations detected in ileum and colon tissue samples from healthy participants.
Dr. Florian Rieder, involved in the study, highlighted the potential of RXC008 as a first-in-class treatment for fibrostenotic Crohn’s disease, a condition that affects millions worldwide and often leads to surgery due to the lack of approved drugs for fibrosis.
Interim Chief Medical (TASE:BLWV) Officer at Redx Pharma, Dr. Helen Timmis, expressed enthusiasm about the results, confirming the compound’s tolerability, tissue exposure, and target engagement. The company is optimistic about the upcoming Phase 2 study slated for later this year.
Crohn’s disease is a chronic inflammatory bowel disease with a global patient population of approximately 1.7 million. Over half of these patients may develop fibrostenotic complications within ten years of diagnosis, necessitating surgical interventions.
The data from this trial, based on a press release statement, indicates a significant step forward in the development of treatments for gastrointestinal fibrosis associated with Crohn’s disease. Redx Pharma’s continued research into RXC008 could potentially offer a new therapeutic option for patients suffering from this debilitating condition.
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