RCS - Redx Pharma Limited - RXC008 Receives US FDA Fast Track Designation

FTI ConsultingAnnouncement

10/03/2026 08:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260310:nRSJ9498Va&default-theme=true

RNS Number : 9498V  Redx Pharma Limited  10 March 2026

REDX PHARMA LIMITED

("Redx" or the "Company")

Redx's RXC008 Granted US FDA Fast Track Designation for Fibrostenotic Crohn's
Disease

Alderley Park, UK, 10 March 2026 Redx Pharma Ltd
(https://www.redxpharma.com/) , the clinical-stage, biotechnology company
focused on developing novel, small molecule, targeted medicines for fibrotic
disease announces that the US Food and Drug Administration (FDA) has granted
Fast Track Designation to RXC008, a GI-Restricted pan-ROCK inhibitor being
developed as a potential first-in-class treatment for fibrostenotic Crohn's
disease.

Lisa Anson, CEO, Redx Pharma commented: "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. These surgeries can
have a significant impact on the physical and emotional wellbeing of these
patients, with many suffering complications such as short-bowel syndrome or
ultimately resulting in the use of a stoma. From our preclinical studies
RXC008 has shown the potential to halt or reverse the formation of fibrosis in
the GI-tract which would revolutionise the treatment of this aspect of the
disease.  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."

About ROCK inhibition and RXC008

Rho-associated coiled-coil forming protein kinase (ROCK) is well established
as an anti-fibrotic target and is known to consist of two isoforms ROCK 1 and
2.  RXC008 is a potent, oral, small molecule non-systemic ROCK1/2 inhibitor
that avoids the significant cardiovascular side effects of systemic pan-ROCK
inhibitors, including tachycardia and hypotension, by being restricted to the
GI-tract via high efflux and low permeability. This results in virtually no
systemic breakthrough, with the molecule being rapidly metabolised by
paraoxonase enzymes in the plasma should any breakthrough occur. RXC008 has
completed a Phase 1 study which showed good tolerability and tissue exposure
with no clinically relevant breakthrough or hypotension observed, and a good
safety profile with no serious adverse events.

About Fast Track Designation 1  (#_ftn1)

Fast track is a process designed to facilitate the development and expedite
the review of drugs to treat serious conditions and fill an unmet medical
need. The purpose is to get important new drugs to the patient earlier. A drug
that receives Fast Track designation may benefit from things such as: more
frequent meetings with FDA to discuss the drug's development plan and ensure
collection of appropriate data needed to support drug approval; more frequent
written communication from FDA about such things as the design of the proposed
clinical trials and use of biomarkers; eligibility for Accelerated Approval
and Priority Review, if relevant criteria are met and; rolling review, which
means that a drug company can submit completed sections of its Biologic
License Application (BLA) or New Drug Application (NDA) for review by FDA,
rather than waiting until every section of the NDA is completed before the
entire application can be reviewed. BLA or NDA review usually does not begin
until the drug company has submitted the entire application to the FDA.

About Crohn's disease

Crohn's disease affects 1.7m 2  (#_ftn2) people globally and >70,000 new
cases are diagnosed each year. More than 50% of patients 3  (#_ftn3) 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. 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                                                 T: +44 (0)1625 469 918

 UK Headquarters

 Caitlin Pearson, Head of Communications

 ir@redxpharma.com (mailto:ir@redxpharma.com)

 FTI Consulting                                                      T: +44 (0)203 727 1000
 Simon Conway/ Ciara Martin

 

 

About Redx Pharma Limited

 

Redx Pharma is a clinical-stage biotechnology company focused on the
development of novel, small molecule, targeted medicine for the treatment of
fibrotic disease. Pioneering the next generation of anti-fibrotic medicines,
the Company is currently progressing RXC008, a first-in-class GI-restricted
pan-ROCK inhibitor for the treatment of fibrostenotic Crohn's disease through
the clinic and has completed a Phase 2a program in idiopathic pulmonary
fibrosis (IPF) with zelasudil, a potential best-in-class selective ROCK2
inhibitor.

 

Additionally, the Company has an early-stage discoidin domain receptor (DDR)
inhibitor program with potential to be a first-in-class approach for chronic
kidney disease. To date, six Redx discovered molecules have been progressed
into the clinic with the Company's accomplishments evidenced not only by its
wholly-owned clinical-stage assets and discovery pipeline, but also by its
strategic transactions including with AstraZeneca and Jazz Pharmaceuticals, as
well as the sale of pirtobrutinib (RXC005, LOXO-305) to Loxo Oncology (Eli
Lilly). Pirtobrutinib, the only approved non-covalent or reversible Bruton's
tyrosine kinase (BTK) inhibitor, has transitioned quickly from FDA approval in
the US, to broader international approvals.

 

 1  (#_ftnref1)
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
(https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track)

 2  (#_ftnref2)  Clarivate, Crohn's disease landscape & forecast p.g. 39,
Published Sep 2022

 

 3  (#_ftnref3) Chan et al, 2018

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAFKLLBQXLLBBB



            Copyright 2019 Regulatory News Service, all rights reserved