RCS - Redx Pharma Limited - Redx new data show zelasudil well-tolerated in IPF

FTI ConsultingAnnouncement

29/09/2025 09:30

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RNS Number : 1905B  Redx Pharma Limited  29 September 2025

 

 

REDX PHARMA LIMITED

("Redx" or the "Company")

Redx presents encouraging signal searching data for zelasudil (RXC007) as a
well-tolerated treatment for Idiopathic Pulmonary Fibrosis at ERS

·    Zelasudil, a potential best-in-class selective ROCK2 inhibitor, shows
evidence of anti-fibrotic activity at 12 and 24 weeks in patients with IPF

·    Zelasudil reduces FVC decline numerically at 12 weeks and continues
to stabilise during open label extension

·    Circulating biomarker data supports the anti-fibrotic signal observed

·    Combinability with standard of care agents demonstrated, with no
treatment related SAE's observed

Alderley Park, UK, 29 September 2025 Redx Pharma (https://www.redxpharma.com/)
, the clinical-stage, biotechnology company focused on developing novel, small
molecule, targeted therapeutics for fibrotic disease, today announces the
presentation of new data from the zelasudil Phase 2a signal searching study in
idiopathic pulmonary fibrosis (IPF) at the European Respiratory Society (ERS)
meeting in Amsterdam. The data were presented by Professor Toby Maher,
zelasudil Phase 2 Chief Investigator and Professor of Clinical Medicine and
Director of the Interstitial Lung Disease Programme at Keck School of Medicine
at the University of Southern California.

Professor Toby Maher said: "The data from this study shows zelasudil has the
potential to improve lung function in IPF patients with relevant circulating
biomarker data that supports the anti-fibrotic activity of the compound.  It
is also exciting to see that zelasudil can be easily combined with standard of
care anti-fibrotic agents."

Zelasudil is a potent, oral, small molecule, selective, Rho Associated
Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor. The Phase 2a study
aimed to assess safety, tolerability, pharmacokinetic and initial efficacy in
patients with IPF. Key secondary endpoints included changes in forced vital
capacity (FVC), circulating biomarkers such as Pro C3 and pharmacokinetic
profiling.

In total, 48 patients participated in the study with baseline demographics and
disease characteristics balanced across treatment groups, and in line with
historical IPF studies. Patients were randomized in a 3:1 ratio to receive
zelasudil or placebo twice daily, for 12 weeks in a double-blind phase at
doses of 20mg BID and 50mg BID. In each cohort, patients were split between
either no background therapy or on stable doses of pirfenidone or nintedanib.
 Upon completing the 12 week double blind treatment period, 35 of the 48
patients enrolled continued into a 12-week open-label extension (OLE) in which
placebo patients were able to cross over to zelasudil.

The study demonstrated that zelasudil was well tolerated at both doses with or
without background antifibrotic therapy. There were no deaths or treatment
related SAEs observed. The most common treatment-related adverse event
reported was asymptomatic ALT / AST increases. All events resolved with
treatment interruption, and there were no associated bilirubin increases or
Hy's law or potential Hy's law cases. There was also no evidence of
hypotension and no GI related signal in the study.

Zelasudil was shown to numerically reduce FVC decline when compared to placebo
at 12 weeks with a 47% reduction in FVC decline (58ml) for patients dosed at
20mg BID and a corresponding 13% reduction in FVC decline (16ml) at 50mg BID.
In the OLE, patients who remained on zelasudil continued to benefit from
treatment for the entire 24-week treatment period, whilst stabilisation in
lung function was also noted in placebo patients who switched to zelasudil.
Circulating biomarker data supports the anti-fibrotic signal observed,
including CA19-9, CA-125, PRO-C3 and CHI3L1.

Pharmacokinetic data matched predictions from Phase 1 healthy volunteer
studies with both doses tested being within the predicted efficacious range.
Combinability with standard of care agents was demonstrated, with no
clinically relevant drug-drug interactions seen with either nintedanib or
pirfenidone.

Dr Helen Timmis, Chief Medical Officer at Redx Pharma added: "IPF is a
devastating disease with no new treatments approved in the last decade. This
signal searching study is very encouraging in demonstrating the tolerability,
combinability and an efficacy signal at this early time point."

These encouraging data support further investigation of zelasudil as a
potential treatment for IPF and other interstitial lung diseases and Redx is
seeking a partner to support the next stages of clinical development.

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/) .

About ROCK2 inhibition and zelasudil

Zelasudil is a potent, oral, small molecule, selective, Rho Associated
Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor. 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.
Pan-ROCK inhibition shows robust anti-fibrotic activity in preclinical models
however, systemic pan-ROCK inhibition results in hypotension. This does not
happen with selective ROCK2 inhibition, and ROCK2 inhibition alone has been
shown to drive anti-fibrotic efficacy in multiple preclinical fibrosis models
including lung, liver, kidney, skin, chronic graft-versus-host disease
(cGvHD), and cancer-associated fibrosis.

 

 

About Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a debilitating disease of the lungs
which progressively causes scarring and a reduction in lung function.
Occurring primarily in older adults (>50 years old), it involves
irreversible and variable scarring, stiffening, and thickening of the lung
tissues, leading to patients experiencing shortness of breath and lack of
oxygen absorption. Over 170,000 patients suffer with IPF i  (#_edn1) and
around a further 53,000 people are diagnosed each year (US, 5 EU, Japan).
Patients diagnosed with IPF have an estimated life expectancy of 3 to 5
years ii  (#_edn2) . There is no known cure, and current treatment only slows
progression of the disease.

 

 For further information, please contact:

 Redx Pharma Limited                                T: +44 (0)1625 469 918

 Cailtin Pearson, Head of Communications

 info@redxpharma.com (mailto:info@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). Pirtobrutinib (RXC005, LOXO-305), the only approved
non-covalent or reversible Bruton's tyrosine kinase (BTK) inhibitor, has
transitioned quickly from first-in-class FDA approval in the US, to broader
international uptake. Pirtobrutinib (RXC005, LOXO-305), now holds either full
or conditional marketing authorisation in four additional key jurisdictions
(EU, China, Japan, South Korea).

 i  (#_ednref1) Patient numbers (diagnosed prevalence) & market size
forecast data sourced from Global Data (US, EU5, Japan)

 

 ii  (#_ednref2) Clinical Estimates from Hyun 2015, Ley 2012, Raghu 2006

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