Redx Pharma Plc (LON:REDX) new management team is continuing to focus its financial resources on progressing its lead candidates in oncology and fibrotic disease into the clinic. When the first patient was treated with RXC004, its porcupine inhibitor, in a Phase I/IIa proof-of-concept trial, some on-target adverse events (anticipated at higher doses) were observed, management took the prudent decision to halt patient recruitment. Based on a draft modified protocol using significantly lower doses, Redx has received positive feedback from the MHRA. Redx is currently preparing the final protocol with the aim of re-starting the clinical study in 1H’19.
Strategy: Redx is focused on the discovery and early clinical development of novel therapeutics in oncology and fibrotic diseases. It is also focused on taking assets through proof-of-concept clinical trials and potentially partnering them to the drug major(s) for late-stage development and commercialisation.
Positive meeting with MHRA: Following suspension of the trial in March 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) has agreed in principle with the proposed plan to re-start of the Phase I/IIa study at a significant lower dose of RXC004, with the aim to start the clinic in 1H’19.
Development strategy for RXC004: Redx proposes to focus the development of RXC004 in combination with a checkpoint inhibitor (CPI) in cancer patients with advanced disease. This is to utilise the specificity of the Wnt pathway in converting immune ‘cold’ tumours to ‘hot’ and improving the CPI response rate.
Risks: After a difficult period, REDX has emerged in much better shape. While all early-stage pharma/biotech companies carry substantial risks and are capital- intensive, the rewards can be substantial, as evidenced by the successful disposal of its pre-clinical BTK programme for $40m in 2017.
Investment summary: Redx Pharma Plc new management team is moving forward with a revised business plan that focuses cash resources on progressing its drug leads in oncology and fibrotic disease to clinical proof-of-concept. With a positive response from the MHRA, patient recruitment in the Phase I/IIa with RXC004 is set to resume early in 2019. While Novartis is paving the way with Wnt inhibition, Redx is a close follower, with a potentially best-in-class compound.