Redx achieves Fast Track Designation in US for Crohn’s disease treatment
Alderley Park-based biotech company Redx Pharma is celebrating a second breakthrough on one of its drugs with an approval from the US Food and Drug Administration (FDA) to grant Fast Track Designation to RXC008.
Addressing an Unmet Need in Fibrostenotic Crohn’s Disease
Currently, fibrostenotic Crohn’s disease presents a significant clinical challenge. Lisa Anson, CEO of Redx Pharma, highlighted the urgent need for new therapies, noting that patients are often left with limited options.
“We are delighted to have received Fast Track designation for RXC008. Currently there is no therapeutic treatment for fibrostenotic Crohn’s disease leaving many patients with invasive, repetitive surgical interventions as their only option.
“Redx have been working closely with the FDA and the STAR consortium to define the regulatory pathway for this disease and following our positive pre-clinical and Phase 1 data, we look forward to commencing our Phase 2 study later this year.”
— Lisa Anson, CEO, Redx Pharma
Mechanism of Action: RXC008
RXC008 is an experimental, oral, small-molecule drug developed by Redx Pharma as a potential first-in-class, gastrointestinal (GI)-restricted pan-ROCK (ROCK1/2) inhibitor for treating fibrostenotic Crohn's disease.
It specifically targets tissue fibrosis (scarring) in the gut, with Phase I studies showing it is well-tolerated and specifically designed to minimize systemic side effects.
A Second FDA Breakthrough and Corporate Updates
This recent FDA milestone follows another significant achievement for the company. In January, theBusinessDesk.com reported that following trials at 31 sites across Europe and the UK, the FDA have agreed to support the further clinical development of Zelasudil, a treatment developed for Idiopathic Pulmonary Fibrosis (IPF).
On the corporate side, Redx Pharma has seen several transitions. Redx left delisted from the London stock exchange’s Alternative Investment Market (AIM) in 2024. Subsequently, in early 2025, the company arranged for a “matched bargain facility” to be provided through the JP Jenkins trading platform, which it has also now left.
