REG - Redx Pharma plc - Redx Presents Encouraging Phase 1 Data for RXC007

Redx PharmaAnnouncement

10/03/2022 07:01

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RNS Number : 2545E  Redx Pharma plc  10 March 2022

REDX PHARMA PLC

("Redx" or "the Company")

 

Redx Presents Encouraging Phase 1 Safety Data for RXC007

 

Data presented at ILD Summit shows this novel anti-fibrotic drug candidate
possesses excellent safety and pharmacokinetic profile

 

Phase 2 study expected to commence in 2022

 

Alderley Park, 10 March 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, today announces encouraging data from the Phase 1 clinical
study of its lead fibrosis asset, RXC007, which was presented at the Virtual
Interstitial Lung Disease Drug Development (ILD) Summit on 9 March 2022 by
Nicolas Guisot PhD, Research Fellow at Redx. Highlights from the data were
also presented at the Cowen 42(nd) Annual Health Care Conference by Lisa
Anson, Chief Executive Officer, on 9 March 2022.

 

The Phase 1 trial (clinicaltrials.gov NCT04931147) is evaluating the safety
and tolerability of RXC007, an orally bioavailable selective ROCK2 (Rho
Associated Protein Kinase 2) inhibitor, in healthy volunteers. Initial data
from this study was presented at Redx's Virtual R&D Day in October 2021
and the data presented at the ILD Summit were from the now completed Phase 1
Single Ascending Dose (SAD) and multiple dose cohorts.

 

The data presented showed RXC007 has an excellent safety and pharmacokinetic
profile in both the SAD and multiple dose phase. No adverse events were
observed following single doses of 2-70mg (dosed once or twice in a day), and
no serious adverse events were observed in the multiple dose phase (dosed at
50mg twice daily for 14 days), with only transient, reversible mild adverse
events observed. The pharmacokinetics observed were as predicted from
preclinical data, with essentially linear exposure for 2-70mg, with
biologically relevant exposures achieved at higher doses. No significant
effect on exposure was seen when dosed with food. The data also showed a
half-life of approximately 9 hours, suitable for once-daily dosing.

 

Additional open-label cohorts will assess the potential for drug-drug
interaction in Part C of the study, which has not yet opened.

 

Based on this profile, Redx confirms plans to commence a staged Phase 2
clinical development program for idiopathic pulmonary fibrosis in 2022. An
initial 12-week randomised placebo-controlled Phase 2a study will assess early
efficacy, safety and tolerability, in addition to target and disease biomarker
engagement, both with and without standard of care agents. The Phase 2a
dose-ranging study will inform the dose selection for subsequent randomised
trials.

 

Lisa Anson, Chief Executive Officer of Redx Pharma, said: "Clinical data from
our Phase 1 study suggests that RXC007 is safe and well-tolerated at the drug
doses we have selected. Importantly, this data supports progressing into Phase
2 studies later this year to assess the safety and efficacy of RXC007 in
patients with idiopathic pulmonary fibrosis, a disease with high unmet medical
need."

 

 For further information, please contact:

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

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

 UK Headquarters

 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 selective ROCK2 inhibitor product
candidate, RXC007, is in development for idiopathic pulmonary fibrosis and
commenced a Phase 1 clinical trial in June 2021. Encouraging safety and
pharmacokinetic data has been reported, and a Phase 2 clinical program is
confirmed to start in 2022.

 

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 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.

 

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