RCS - Redx Pharma Limited - Redx presents Ph1 data supporting RXC008 at DDW

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RNS Number : 2919H  Redx Pharma Limited  06 May 2025

 

 

REDX PHARMA LIMITED

("Redx" or the "Company")

 

Redx presents  Phase 1 data supporting RXC008 as a novel and well tolerated
drug candidate in development for the potential treatment of
fibrostenotic Crohn's disease

Orally administered pan-ROCK inhibitor demonstrated intestinal tissue exposure
and target engagement with minimal plasma concentrations

A Phase 2 study is being planned

Alderley Park, UK, 6 May 2025 Redx Pharma (https://www.redxpharma.com/) , the
clinical-stage, small molecule biotechnology company focused on tackling
fibrosis, today announces the presentation of additional results from an
RXC008 Phase 1 clinical trial.  The poster will be presented by Dr Florian
Rieder, Vice Department Chair, Co-Section Director Inflammatory Bowel
Diseases, Director Cleveland Clinic Program for Global Translational
Inflammatory Bowel Diseases, Cleveland Clinic, USA, at Digestive Disease
Week® 2025, San Diego, CA & Online, Sunday 4 May, 2025.

RXC008 is a highly potent pan-Rho-associated coiled-coil kinase (pan-ROCK)
inhibitor that was designed to be restricted to the gastrointestinal (GI)
tract. The Phase 1 study aimed to assess the safety, tolerability, local and
systemic exposure of RXC008 in healthy participants as part of a clinical
development programme for intestinal fibrosis, such as that associated with
Crohn's disease.

The study demonstrated that RXC008 was well tolerated with no safety signals
at any tested dose (up to 1000mg as a single oral dose and up to 300mg dosed
daily over 14 days). There were no adverse events (AEs) reported in the single
ascending dose (SAD) study. In the multiple ascending dose (MAD) study, all
AEs were mild or moderate with no trends observed. There were no serious
adverse events and no AEs leading to treatment discontinuation. Importantly,
no hypotension or tachycardia (known liabilities of systemic pan-ROCK
inhibition) were observed in any participant.

Robust data was generated during the study that confirmed the drug to be
gut-restricted. Minimal systemic exposure was observed even at daily RXC008
doses of 300mg, when predicted efficacious concentrations of RXC008 were
detected in tissue samples obtained from healthy participants ileum and colon
via ileocolonoscopy at Day 14 during the MAD section of the trial. The study
also confirmed a potential target engagement marker that can be taken forward
into the clinic.

Dr Florian Rieder, M.D., Vice Department Chair, Co-Section Director
Inflammatory Bowel Diseases, Director Cleveland Clinic Program for Global
Translational Inflammatory Bowel Diseases, Cleveland Clinic, USA, said: "The
results of this Phase 1 study for RXC008 further demonstrates the
first-in-class potential for a novel treatment for fibrostenotic Crohn's
disease. It is very reassuring to see data that demonstrates RXC008 is well
tolerated in healthy volunteers with early signs of a target engagement marker
identified."

Dr Helen Timmis, Interim Chief Medical Officer at Redx Pharma added: "Our
ambition at the start of this study was to confirm the compound was well
tolerated with good tissue exposure and minimal systemic exposure. It's
exciting to have confirmed this as well as confirming a potential target
engagement marker. It's a fantastic position to be in ahead of commencing a
Phase 2 study later this year."

A copy of the abstract presentation deck is available on the Company website
at: https://www.redxpharma.com/scientific-publications
(https://www.redxpharma.com/scientific-publications) .

Phase 1 clinical study overview

The Phase 1 clinical study consisted of a single ascending dose (SAD) followed
by a multiple ascending dose (MAD) study. In the SAD, 6 cohorts were
randomised 2:1 to single oral doses of RXC008 or placebo between 10 and
1000mg. In the MAD, 3 cohorts were randomised 3:1 to RXC008 or placebo daily,
at doses of 30, 100 and 300mg, for 14 days. Safety, tolerability and systemic
exposure were assessed in both parts. 24-hour blood pressure monitoring and
telemetry were used to evaluate hypotensive effects in the SAD and in the
first cohort of the MAD. MAD participants underwent Day 14 ileocolonoscopy to
assess tissue drug concentrations in biopsies from the ileum and colon.

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.

 

About Crohn's disease

 

Crohn's disease affects 1.7m i  people globally and >70,000 new cases are
diagnosed each year. More than 50% of patients ii  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

 Erin Hamid, Interim 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. Redx aims to progress its programmes to clinical proof of
concept before evaluating options for further development and potential value
creation. The Company is currently progressing an industry-leading ROCK
inhibitor portfolio through the clinic, comprising of zelasudil, a selective
ROCK2 inhibitor for the treatment of interstitial lung diseases including
idiopathic pulmonary fibrosis, and RXC008, a GI-restricted pan-ROCK inhibitor
for the treatment of fibrostenotic Crohn's disease. Additionally, the Company
has a Phase 2 precision oncology programme which it intends to partner for
further development.

The Company has a strong track record of discovering new drug candidates
through its core strengths in medicinal chemistry, translational science and
clinical development, enabling the Company to discover and develop
differentiated therapeutics against biologically or clinically validated
targets. 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 product candidates and discovery pipeline, but
also by its strategic transactions, which include the sale of pirtobrutinib
(RXC005, LOXO-305), the only non-covalent or reversible BTK inhibitor, now
approved by the US FDA, and transactions with both AstraZeneca and Jazz
Pharmaceuticals.

 

 i  Clarivate, Crohn's disease landscape & forecast p.g. 39, Published Sep
2022

 ii  Chan et al, 2018

 

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