REG - Redx Pharma plc - Progress Update on RXC007 Clinical Programme

Redx PharmaAnnouncement

09/02/2023 07:00

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RNS Number : 3787P  Redx Pharma plc  09 February 2023

REDX PHARMA PLC

 

("Redx" or the "Company")

 

Redx Provides Progress Update on RXC007 Clinical Programme

 

Actively recruiting patients in multiple sites across five European
countries

 

US recruitment in 28-day cohort ongoing, longer-term dosing under partial
clinical hold pending additional non-clinical data reporting during 2023

 

Topline Phase 2a data expected in Q1 2024

Alderley Park, UK, 9 February 2023 Redx (AIM:REDX), the clinical-stage
biotechnology company focused on discovering and developing novel, small
molecule, highly targeted therapeutics for the treatment of cancer and
fibrotic disease, announces a progress update on lead fibrosis candidate
RXC007. RXC007 is an oral, selective Rho Associated Coiled-Coil Containing
Protein Kinase 2 (ROCK2) inhibitor which is currently being assessed in a
Phase 2a study in idiopathic pulmonary fibrosis (IPF).

 

The Phase 2a IPF study is a multi-cohort, randomised, double-blind,
placebo-controlled dose ranging study to assess safety and tolerability over a
12-week dosing period, as well as early signals of efficacy. In parallel, the
study incorporates a translational science sub-study to evaluate target
engagement and fibrosis modification over a 28-day dosing period.

 

Following the announcement on 11 October 2022 of first patient enrolment in
the trial, regulatory and ethics approvals for both the 28-day and the 12-week
cohorts have been received in five countries across Europe, and recruitment is
progressing at a number of study sites. Additionally, there is an open IND in
the US and study sites are currently being initiated, allowing enrolment into
the 28-day translational science sub-study. US enrolment into the 12-week
cohorts of the study has not commenced and is currently under an FDA partial
clinical hold pending the data readout from an ongoing non-clinical programme.
The requested data, at clinically relevant doses, is expected later this year
and Redx believe will support the longer dosing duration. Ongoing US site set
up and enrolment into the 28-day cohort is unaffected.

 

Overall, based on the current patient recruitment rate, topline data from this
Phase 2a study are expected to be available in Q1 2024.

 

Lisa Anson, Chief Executive Officer, Redx Pharma, commented, "We are pleased
to be actively recruiting our Phase 2a IPF study in both Europe and the US,
putting us in a position to report topline data from both the 12-week and
28-day cohorts in Q1 2024. We expect our ongoing non-clinical programme to
provide the data during 2023 to address the FDA request and support longer
term dosing in the US.  We have strong capabilities in creating
next-generation products - as shown by our discovery of a next-generation BTK
inhibitor - and we are excited about the potential of our next-generation
ROCK2 inhibitor, RXC007, to treat a range of fibrotic conditions where there
exists a significant unmet medical need."

 

ROCK2 inhibition is now a commercially validated target with potential in
multiple disease areas, following the recent FDA approval and launch of the
first drug with this mechanism of action for the treatment of chronic graft
versus host disease (cGvHD). In addition to the ongoing clinical development
plan in IPF, Redx has also generated consistently supportive preclinical data
that highlights the broad potential of next-generation ROCK2 inhibitors across
a number of fibrotic indications where there remains a significant unmet need.
Redx recently presented proof-of-concept data at the International Colloquium
on Lung and Airway Fibrosis (ICLAF)(1) that detailed development work in
immune mediated models of cGvHD, where the underlying disease mechanisms that
drive pathology in the model show similarities to those observed in the lung
pathology of auto-immune driven fibrotic diseases such as systemic sclerosis
and interstitial lung disease (ILD). Furthermore, encouraging data from an
ongoing collaboration with the Garvan Institute of Medical Research, presented
at the Antifibrotic Drug Development Summit (AFDD)(2), has shown the potential
of Redx's ROCK2 inhibitors in cancer-associated fibrosis, such as that seen in
pancreatic cancer. Redx plans to provide updates on further development as
appropriate.

 

 For further information, please contact:
 Redx Pharma Plc                                 T: +44 (0)1625 469 918

 UK Headquarters

 Caitlin Pearson, Head of Communications

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

 Lisa Anson, Chief Executive Officer

 US Office

 Peter Collum, Chief Financial Officer

 SPARK Advisory Partners (Nominated Adviser)     T: +44 (0)203 368 3550
 Matt Davis/ Adam Dawes

 WG Partners LLP (Joint Broker)                  T: +44 (0)203 705 9330
 Claes Spång/ Satheesh Nadarajah/ David Wilson

 Panmure Gordon (UK) Limited (Joint Broker)      T: +44 (0)207 886 2500
 Rupert Dearden/ Freddy Crossley/ Emma Earl

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

 

About Redx Pharma Plc

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on
the discovery and development of novel, small molecule, highly targeted
therapeutics for the treatment of cancer and fibrotic disease and the emerging
area of cancer-associated fibrosis, aiming initially to progress them to
clinical proof of concept before evaluating options for further development
and potential value creation. The Company's lead fibrosis product candidate,
the selective ROCK2 inhibitor RXC007, is in development for interstitial lung
disease and commenced a Phase 2a trial for idiopathic pulmonary fibrosis (IPF)
in October 2022. Redx's lead oncology product candidate, the Porcupine
inhibitor RXC004, being developed as a targeted treatment for Wnt-ligand
dependent cancers, commenced a Phase 2 programme in November 2021.  Redx's
third drug candidate, RXC008, a GI-targeted ROCK inhibitor for the treatment
of fibrostenotic Crohn's disease, is progressing towards a CTA/IND application
at the end of 2023.

 

The Company has a strong track record of discovering new drug candidates
through its core strengths in medicinal chemistry and translational science,
enabling the Company to discover and develop differentiated therapeutics
against biologically or clinically validated targets. The Company's
accomplishments are evidenced not only by its two wholly-owned clinical-stage
product candidates and rapidly expanding pipeline, but also by its strategic
transactions, including the sale of pirtobrutinib (RXC005, LOXO-305), a
non-covalent (reversible) BTK inhibitor now approved by the US FDA for adult
patients with mantle cell lymphoma previously treated with a covalent BTK
inhibitor, and AZD5055/RXC006, a Porcupine inhibitor targeting fibrotic
diseases including IPF, which AstraZeneca is progressing in a Phase 1 clinical
study. In addition, Redx has forged collaborations with Jazz Pharmaceuticals,
which includes JZP815, a pan-RAF inhibitor developed by Redx which Jazz is now
progressing through Phase 1 clinical studies and an early stage oncology
research collaboration.

 

To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/
(http://www.redxpharma.com/investor-centre/email-alerts/)

 

About the RXC007 Phase 2a Clinical study in IPF

The Phase 2a study is a 12-week multi-cohort, randomised, double-blind,
placebo-controlled dose ranging study to assess early signals of efficacy as
well as the safety and tolerability of RXC007 in IPF patients. Both
treatment-naïve patients and patients already on approved IPF therapy will be
included in the study. Key endpoints for the study will be safety and
pharmacokinetic profile; changes from baseline in lung function of forced
vital capacity (FVC) and carbon monoxide diffusion coefficient (DLCO); and
changes from baseline in Quantative Lung Fibrosis Score (QLFS), airway volume
and resistance on high resolution computerised tomography (HRCT) scan.

 

In the study three dose escalation cohorts of 16 patients will be assigned a
dosing period of three months, with patients potentially continuing for longer
if they are seen to be tolerating their assigned treatment and there are no
signs of disease progression.

 

As part of the study, a 28-day translational science sub-study will commence
in parallel to evaluate target engagement and disease interaction. Endpoints
for this sub-study will include changes from baseline in blood biomarkers,
proteins and genes from broncho-alveolar lavage (BAL) fluid, BAL-fluid cells
and bronchial epithelial cells.

 

 

1.
https://www.redxpharma.com/wp-content/uploads/2022/10/RXC007_ICLAF_Poster_2022-10-01_FINAL-1.pdf
(https://www.redxpharma.com/wp-content/uploads/2022/10/RXC007_ICLAF_Poster_2022-10-01_FINAL-1.pdf)

2.
https://www.redxpharma.com/wp-content/uploads/2023/02/RXC007_ROCK2_AFDD_11Nov2022_FINAL.pdf
(https://www.redxpharma.com/wp-content/uploads/2023/02/RXC007_ROCK2_AFDD_11Nov2022_FINAL.pdf)

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