UK based Biotechnology Company, Redx has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given formal approval to the Company to re-commence the phase 1/2a trial for RXC004, an oral porcupine inhibitor targeting the Wnt signalling pathway.

Clinical evaluation of RXC004 in patients with advanced solid tumours remains on track to resume in H1 2019 following the approval of a revised phase 1/2a clinical trial protocol and drug formulation.  Redx, together with the study investigators, now believe that the desired systemic exposure can be achieved using a significantly lower starting dose with the potential for clinical benefit.

Natalie Cook, Consultant Oncologist and Principal Investigator from the Christie Hospital in Manchester, UK commented, “We have learnt a significant amount from the first patient treated with RXC004, and this provides the basis for an optimised RXC004 development plan as well as the confidence to evaluate the clinical potential of RXC004 in cancer patients.”

Lisa Anson, Chief Executive Officer, Redx Pharma plc commented, “I am delighted that Redx is on track to resume clinical evaluation of RXC004 in patients with advanced solid tumours in the first half of 2019. We believe that the revised RXC004 clinical protocol and development plan has the potential to offer clinical benefit both as a monotherapy and in combination with standard of care treatments. We look forward to working closely with our expert clinical oncology colleagues across the U.K. on this exciting programme.”

On successful completion of this initial phase 1 monotherapy study, RXC004 has the potential to be developed in different cancers and in different treatment settings with major unmet medical need based on two distinct mechanisms of actions: as an immuno-oncology agent and by direct tumour targeting in patients with upstream Wnt signalling pathway alterations.