RCS — Redx Pharma Limited — Redx to Present Poster on RXC008 at UEG Week
For best results when printing this announcement, please click on link below: RNS Number: 2053Z Redx Pharma Limited 16 October 2026 Redx Pharma Ltd Redx to Present Poster on Phase 2 ROCKETEER Clinical Trial Design for RXC008 at United European Gastroenterology Week and Participates in Innovation Hub Alderley Park, UK, October 16, 2026, Redx Pharma Ltd ("Redx" or the "Company"), a clinical-stage biotechnology company focused on developing novel, small molecule, targeted medicines for fibrotic disease, today announced that the Company will present the Phase 2 ROCKETEER clinical trial design in fibrostenotic Crohn's disease (FSCD) for its lead asset, RXC008, a GI-restricted pan-ROCK inhibitor, in a poster presentation at the United European Gastroenterology (UEG) meeting on October 17-20, 2026 in Barcelona, Spain. The Phase 2 ROCKETEER trial's primary objective is to assess the safety and efficacy of RXC008 in participants with small bowel strictures due to Crohn's disease who are on stable background anti-inflammatory therapy. The primary endpoint is the absolute change from baseline in the primary stricture length as measured by Magnetic Resonance Enterography (MRE) at week 24, a ke
For best results when printing this announcement, please click on link below: RNS Number: 2053Z Redx Pharma Limited 16 October 2026 Redx Pharma Ltd Redx to Present Poster on Phase 2 ROCKETEER Clinical Trial Design for RXC008 at United European Gastroenterology Week and Participates in Innovation Hub Alderley Park, UK, October 16, 2026, Redx Pharma Ltd ("Redx" or the "Company"), a clinical-stage biotechnology company focused on developing novel, small molecule, targeted medicines for fibrotic disease, today announced that the Company will present the Phase 2 ROCKETEER clinical trial design in fibrostenotic Crohn's disease (FSCD) for its lead asset, RXC008, a GI-restricted pan-ROCK inhibitor, in a poster presentation at the United European Gastroenterology (UEG) meeting on October 17-20, 2026 in Barcelona, Spain.
The Phase 2 ROCKETEER trial's primary objective is to assess the safety and efficacy of RXC008 in participants with small bowel strictures due to Crohn's disease who are on stable background anti-inflammatory therapy. The primary endpoint is the absolute change from baseline in the primary stricture length as measured by Magnetic Resonance Enterography (MRE) at week 24, a key objective measure of stricture morphology and novel approach to monitoring disease progression. Mei-Lun Wang, M.D., Chief Medical Officer, and Caroline Phillips, Ph.D., Chief Scientific Officer, will present the Phase 2 design along with supportive Phase 1 data in healthy volunteers.
"We are excited to be at UEG this year, where we will present our Phase 2 ROCKETEER trial design. ROCKETEER has the potential to generate a rich, multidimensional dataset using a novel radiographic endpoint as its primary measure of efficacy and multiple clinically relevant and objective endpoint features," said Mei-Lun Wang, M.D., Chief Medical Officer, Redx. "We are also excited to participate at the UEG Innovation Hub.
Fibrostenotic Crohn's disease is one of the highest areas of unmet need in inflammatory bowel disease and we look forward to productive and educational discussions with KOLs, clinicians and industry peers at the conference and at the Innovation Hub as we work together to improve the outlook for patients living with FSCD." Poster Presentation Details: Title: RXC008: First-in-class gastrointestinal-targeted potent pan-ROCK inhibitor for treatment of Fibrostenotic Crohn's Disease Session: Fibrosis in IBD Day/Date: Sunday, October 18 Presentation Time: 10:30am CEST Location: Hall 7, Poster Stage 3 Innovation Hub Presentations: Session: Beyond Anti-Inflammatories: ROCKing a New Anti-Fibrotic Treatment Paradigm Day/Date/Time: Sunday, October 18: 11:30am-12:00pm CEST Monday, October 19: 9:30-10:00am & 11:00-11:30am CEST Tuesday, October 20: 9:30-10:00am & 14:00-14:30am CEST Location: UEG Innovation Hub About the ROCKETEER Phase 2 Trial The ROCKETEER Phase 2 trial (NCT07832435) is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered RXC008 compared to a matching placebo over a treatment period of up to 48 weeks.
The trial is expected to enroll approximately 180 patients, across North America, Europe and UK. Eligible participants must be on stable background anti-inflammatory therapy and must have ≤2 small bowel strictures (naïve, native or anastomotic in nature), confirmed by a centrally-read MRE with the primary lesion most distal and reachable by ileocolonoscopy. Participants will be randomized 1:1:1 to receive either a high dose of RXC008, a low dose of RXC008, or a matching placebo, administered orally. The primary endpoint will be the absolute change from baseline in primary stricture length as measured by MRE at week 24.
A comparable MRE will also be performed at week 48. The trial will also assess a number of key secondary efficacy and safety endpoints including; · Change from baseline in stricture passability (passable or non-passable) via ileocolonoscopy at weeks 24 and 48; · Radiographic stenosis response showing ≥25% improvement in primary stricture length or ≥50% improvement in pre-stenotic dilation at weeks 24 and 48, as assessed by MRE; · Change from baseline in Stenosis-Patient-Reported Outcome version 2 (S-PRO2) scores at weeks 24 and 48; · Regular blood sampling will also be conducted to characterize systemic drug exposure and safety profile.
For more information, the clinicaltrials.gov entry is available here About RXC008 RXC008 is a highly potent, selective, oral, GI-restricted small-molecule pan-ROCK inhibitor, which is being developed as a treatment for patients with FSCD. Rho-associated coiled-coil-containing protein kinase (ROCK) is a well-established anti-fibrotic target that sits at a key junction that regulates various cell signaling pathways central to fibrosis, providing a pleiotropic effect. The ROCK signaling pathway is upregulated in Crohn's disease, and expression of both ROCK1 and ROCK2 isoforms has been demonstrated in Crohn's patients' fibrotic strictures.
Inhibiting both ROCK1 and ROCK2 (pan-ROCK inhibition) could have the greatest anti-fibrotic potential in this indication. Systemic pan-ROCK inhibition is limited by known associated cardiovascular side effects, including hypotension, and therefore RXC008 was specifically designed to avoid these side effects by being GI-restricted through high efflux and low permeability. RXC008 is also rapidly metabolized by paraoxonase enzymes in the plasma and by the liver, which results in virtually no systemic exposure. This was demonstrated in the RXC008 Phase 1 trial in healthy volunteers, which showed therapeutic tissue concentrations and no hypotension at any dose tested.
RXC008 received Fast Track Designation for the treatment of FSCD from the FDA in February 2026, which allows more frequent interactions with the FDA, and the Company continues to actively work with the agency to receive ongoing guidance about the clinical trial design, including evaluation of clinical and radiological responses. About Crohn's Disease Crohn's disease affects 1.7m(1) people globally and >70,000 new cases are diagnosed each year.
More than 50% of patients(2) with Crohn's disease can develop significant fibrosis and stricture formation within ten years after diagnosis; this fibrosis associated with Crohn's disease is known as fibrostenotic Crohn's disease (FSCD). The current management of fibrotic strictures of the gastrointestinal tract is primarily surgical as no drugs are specifically approved for fibrosis, which can progress despite intervention with anti-inflammatory therapies. (1) Clarivate, Crohn's disease landscape & forecast p.g.
39, Published Sep 2022 (2) Chan et al, 2018 About Redx Redx is a clinical-stage biotechnology company focused on the development of novel, small molecule, targeted medicines for the treatment of fibrotic disease, developing therapeutic treatment options in areas of high unmet need. The Company is developing therapies targeting the ROCK pathway and its lead asset RXC008, a GI-restricted pan-ROCK inhibitor for the treatment of fibrostenotic Crohn's disease, is anticipated to commence the Phase 2 ROCKETEER clinical trial in the fourth quarter of 2026.
The Company's pipeline also includes zelasudil (RXC007), a next-generation selective ROCK2 inhibitor, and a novel Discoidin Domain Receptor (DDR) program targeting chronic kidney disease, currently in pre-clinical development.
For further information, please contact: Redx Pharma Limited UK Headquarters Caitlin Pearson, Head of Communications ir@redxpharma.com (mailto:ir@redxpharma.com) For investors: LifeSci Advisors redx@lifesciadvisors.com (mailto:redx@lifesciadvisors.com) Cautionary note regarding forward looking statements This communication contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "believe," "expect," "plan," "anticipate," "aim," "continue," "target" and similar expressions are intended to identify forward-looking statements.
All statements, other than statements of historical facts, included in this communication are forward-looking statements.
These statements include, but are not limited to, statements regarding: forecasts and estimates with respect the design, anticipated commencement, duration, timing, enrolment, scope, costs, funding, clinical trial data releases and publications of Redx's planned and ongoing trials, including the Phase 2 ROCKETEER clinical trial with RXC008 in patients with FSCD, and the information, insights and impacts that may be gathered from those trials; the potential therapeutic benefits of RXC008; the potential benefits of having received Fast Track Designation; potential regulatory submissions, approvals and commercialization; the potential of RXC008 as a GI-restricted pan-ROCK inhibitor treatment for FSCD; and the potential of zelasudil (RXC007) and the DDR inhibitor programme.
Any forward-looking statements are based on management's current expectations and beliefs and are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by such statements, many of which are beyond Redx's control. These risks and uncertainties include, but are not limited to: the risk that the transaction with Skye Bioscience, Inc.
may not be completed on the anticipated timeline, or at all; the impact of worsening macroeconomic conditions on Redx's business, financial position and anticipated milestones; Redx's ability to conduct ongoing and planned clinical trials; Redx's ability to obtain clinical or commercial supply of its product candidates; Redx's ability to obtain and maintain regulatory approval of its product candidates; Redx's ability to demonstrate the safety and efficacy of its product candidates and gain approval on a timely basis, if at all; delays in clinical trials, whether due to patient enrollment or otherwise; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies; Redx's need for and ability to obtain additional funding, on favorable terms or at all; Redx's ability to obtain, maintain and enforce intellectual property protection for its product candidates; and the success of Redx's collaborations, partnerships or licensing arrangements.
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