Redx Announces Design of ROCKETEER Phase 2 Trial for RXC008 in Fibrostenotic Crohn’s Disease

• Phase 2 ROCKETEER trial design guided by U.S. Food and Drug Administration (FDA) input, including primary endpoint of stricture length as measured by Magnetic Resonance Enterography (MRE) along with other key secondary endpoints including clinical and biological assessments
• ROCKETEER on track to enroll first patient during 2026

Alderley Park, UK, 28 September 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 the Phase 2 ROCKETEER clinical trial design for its lead asset, RXC008, a GI-restricted, pan-ROCK inhibitor for the treatment of fibrostenotic Crohn’s disease (FSCD).

More than 50% of patients1 with Crohn’s disease can develop FSCD and stricture formation within ten years following diagnosis. There is currently no approved therapeutic treatment that specifically targets the fibrotic aspects of the disease. Current management of fibrotic strictures is invasive and costly, including surgical intervention with additional hospitalizations and treatment. This creates a significant health economic burden in an area of high unmet need.

The Phase 2 ROCKETEER trial design follows extensive discussions with the FDA, and collaboration with key opinion leaders, to develop the optimal overall clinical development strategy and relevant regulatory endpoints for this underserved patient population. The 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 MRE at week 24, a key objective measure of stricture morphology and novel approach to monitoring disease progression.

“The ROCKETEER trial represents an exciting milestone for the field, incorporating a novel radiographic endpoint as its primary measure of efficacy, as discussed with the FDA, along with a comprehensive range of other clinical and biological assessments. By leveraging advanced imaging techniques and multiple clinically relevant and objective endpoints, the study will generate a rich, multidimensional dataset. This trial provides an opportunity to directly assess treatment effects on changes in stricture morphology, deepening our understanding of disease activity and treatment effects in Crohn's disease and the potential efficacy of RXC008” commented Mei-Lun Wang, MD, Chief Medical Officer of Redx. “We look forward to working closely with regulators and the clinical community as we initiate patient recruitment, expected later this year, bringing us closer to hopefully developing an effective treatment for a patient population with limited therapeutic options.”

About the ROCKETEER Phase 2 Trial

The ROCKETEER Phase 2 trial (NCT07832435) is a randomized, double-blind, placebo-controlled study 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 enrol 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 theagency to receive ongoing guidance about the clinical trial design, including evaluation of clinical and radiological responses.

About Crohn’s Disease

Crohn's disease affects 1.7m2 (bookmark://_bookmark1) people globally and >70,000 new cases are diagnosed each year. More than 50% of patients3 (bookmark://_bookmark2) 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.

For further information, please contact:

Redx Pharma Limited UK Headquarters

Caitlin Pearson, Head of Communications

ir@redxpharma.com

FTI Consulting

T: +44 (0)203 727 1000

Simon Conway

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.

2 Clarivate, Crohn’s disease landscape & forecast p.g. 39, Published Sep 2022

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 to Redx’s Phase 2 ROCKETEER clinical trial with RXC008 in patients with FSCD, including the design, duration, timing, enrolment, costs, and funding, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of RXC008, potential regulatory submissions, approvals and commercialization; the potential of RXC008 as a GI-restricted pan-ROCK inhibitor treatment for FSCD; the potential of zelasudil (RXC007) and the DDR inhibitor programme, including the expected timing of IND submissions; regulatory filings and approvals, including the timing thereof; expectations regarding the design, progress, timing, enrollment, scope, funding and results of Redx’s planned and ongoing clinical trials. 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 enrolment 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 favourable 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. All information in this communication is as of the date of its release, and Redx undertakes no duty to update this information, except as required by law.