REG - Redx Pharma plc - First Patient Dosed in Phase 2a Trial for RXC007

Redx PharmaAnnouncement

11/10/2022 07:00

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RNS Number : 4067C  Redx Pharma plc  11 October 2022

REDX PHARMA PLC

("Redx" or "the Company")

 

Redx Announces First Patient Dosed in Phase 2a Trial for RXC007

 

Study in idiopathic pulmonary fibrosis patients to assess early signals of
efficacy, safety and tolerability

 

RXC007 is Redx's second wholly-owned compound to enter Phase 2 clinical
studies

 

Alderley Park, UK, 11 October 2022 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 the first patient has been dosed in the Phase 2a
study assessing RXC007, a wholly-owned Rho Associated Coiled-Coil Containing
Protein Kinase 2 (ROCK2) selective inhibitor, as a potential treatment for
patients with idiopathic pulmonary fibrosis (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.

 

A 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.

 

It is anticipated that headline data from the Phase 2a study will be available
in H2 2023.

 

Lisa Anson, Chief Executive Officer, Redx Pharma commented: "We are extremely
pleased to commence this Phase 2a trial for RXC007 in IPF, a truly
devastating, rapidly progressing and ultimately deadly disease, where there
are few treatment options. ROCK2 is a biologically-validated target shown
preclinically to reduce fibrosis, the key pathology of IPF. The encouraging
preclinical and translational data for RXC007 have given us confidence to
progress into a Phase 2 programme with IPF as the lead indication.

 

"RXC007 will be the second wholly-owned Redx programme to enter Phase 2
clinical studies, reflecting our strong progress as a Company. It is one of
five compounds to come from the Redx discovery engine that are currently at
the clinical development stage, a testament to the strength of our world-class
medicinal chemistry expertise and drug discovery capabilities."

 

Prof Philip Molyneaux, the Asthma and Lung UK Chair of Respiratory Research
and director of the NIHR Cardiorespiratory Clinical Research Facility at the
Royal Brompton Hospital, the Chief Investigator for the RXC007 trial in the
UK, commented: "IPF is a chronic disease with significant unmet medical need
and limited therapeutic treatment options. ROCK, a known masterswitch in the
fibrotic signalling pathway, is a promising target, which is heavily
upregulated in IPF patients but has historically been very difficult to
selectively inhibit. RXC007 Phase 1 data showed an excellent safety and
pharmacokinetic profile in both the single ascending dose and multiple dose
phase, and I look forward to supporting this Phase 2 trial."

 

About RXC007

RXC007 is an orally available, highly selective small molecule inhibitor that
targets Rho Associated Coiled- Coil Containing Protein Kinase 2 (ROCK2) which
sits at a nodal point in a cell signalling pathway, believed to be central to
fibrosis. ROCK2 selectivity is important to avoid systemic hypotension, a
serious cardiovascular side effect which has been seen in product candidates
that systemically inhibit both ROCK1 and ROCK2. As a selective ROCK2
inhibitor, RXC007 has the potential to treat several fibrotic diseases and has
demonstrated robust anti-fibrotic effects in a range of industry-standard in
vivo preclinical models, results of which were recently presented at the
International Colloquium on Lung and Airway Fibrosis (ICLAF) Redx intends to
evaluate RXC007 initially as a treatment for idiopathic pulmonary fibrosis
(IPF), a severe and life-threatening chronic lung condition with limited
treatment options, which is estimated to affect 170,000((1)) patients
globally. IPF has an addressable market opportunity estimated to be
worth $3.6 billion by 2029((1)).

 

About Idiopathic Pulmonary Fibrosis

Fibrosis is an internal scarring process, which can occur in response to
injury, where excess connective tissue is deposited in an organ or tissue,
thereby impairing its function. Most chronic inflammatory diseases will result
in fibrosis, with progressive injury resulting in organ failure. Idiopathic
pulmonary fibrosis refers to scarring in the lungs which leads to difficulty
in breathing. The specific cause of fibrosis is not known, but it can occur as
a result of many different diseases and underlying health issues, including
obesity or diabetes. Current therapeutic options are limited for these chronic
and often life-threatening diseases.

 

 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 diseases, aiming
initially to progress them to clinical proof of concept before evaluating
options for further development and potential value creation. Redx's lead
oncology product candidate, the Porcupine inhibitor RXC004, commenced a Phase
2 programme in November 2021. 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 in
October 2022. Redx's third drug candidate, RXC008, a GI-targeted ROCK
inhibitor for the treatment of fibrostenotic Crohn's disease, is currently in
pre-IND stage, with Phase 1 clinical studies expected to commence in 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 BTK
inhibitor now in Phase 3 clinical development by Eli Lilly following its
acquisition of Loxo Oncology and AZD5055/RXC006, a Porcupine inhibitor
targeting fibrotic diseases including idiopathic pulmonary fibrosis (IPF),
which AstraZeneca is progressing in a Phase 1 clinical study. In addition,
Redx has forged collaborations with Jazz Pharmaceuticals, which includes
JZP815, a preclinical pan-RAF inhibitor which has received IND clearance from
the US FDA, and an early stage oncology research collaboration.

 

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(http://www.redxpharma.com/investor-centre/email-alerts/)

 

(1) GlobalData IPF report 2019. IPF Market size forecast data sourced from
Global Data (based on 7-8 major markets/2029 estimates)

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