Redx has secured approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to restart a phase 1/2a trial for its cancer candidate RXC004 in advanced solid tumors.
An oral porcupine inhibitor, RXC004 has been designed to target the Wnt signaling pathway. The early-stage trial of the small molecule drug was temporarily stopped in March 2018 after significant adverse events were observed following the dosing of the first patient.
Redx said that clinical evaluation of the investigational drug remains on track to restart in the first half of this year following the MHRA’s approval of a revised phase 1/2a clinical trial protocol and drug formulation.
The company said that along with the study investigators, it believes that the desired systemic exposure can be achieved with a considerably lower starting dose with the potential for clinical benefit.
The phase 1/2a trial was stopped previously by the company to rectify the dose-escalation procedure and for restarting it at lower dose levels. Redx, then said that analysis from the first patient indicated that the systemic RXC004 exposure was a lot higher than what was expected based on the preclinical studies.
The trial’s principal investigator Natalie Cook from Christie Hospital said:
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.
Redx said that upon successful completion of the early-stage monotherapy study, RXC004 has the potential to be developed for various cancers and in multiple treatment settings with major unmet medical need. This will be based on two distinct mechanisms of actions, one as an immuno-oncology agent and the other by direct tumor targeting in patients with upstream Wnt signaling pathway alterations, said the company.
Redx Pharma CEO Lisa Anson said: “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.”