Redx Provides Progress Update on RXC007 Clinical Programme
pharmafile | February 9, 2023 | News story | Business Services |
Alderley Park, UK, 9 February 2023 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 a progress update on lead fibrosis candidate RXC007. RXC007 is an oral, selective Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor which is currently being assessed in a Phase 2a study in idiopathic pulmonary fibrosis (IPF).
The Phase 2a IPF study is a multi-cohort, randomised, double-blind, placebo-controlled dose ranging study to assess safety and tolerability over a 12-week dosing period, as well as early signals of efficacy. In parallel, the study incorporates a translational science sub-study to evaluate target engagement and fibrosis modification over a 28-day dosing period.
Following the announcement on 11 October 2022 of first patient enrolment in the trial, regulatory and ethics approvals for both the 28-day and the 12-week cohorts have been received in five countries across Europe, and recruitment is progressing at a number of study sites. Additionally, there is an open IND in the US and study sites are currently being initiated, allowing enrolment into the 28-day translational science sub-study. US enrolment into the 12-week cohorts of the study has not commenced and is currently under an FDA partial clinical hold pending the data readout from an ongoing non-clinical programme. The requested data, at clinically relevant doses, is expected later this year and Redx believe will support the longer dosing duration. Ongoing US site set up and enrolment into the 28-day cohort is unaffected.
Overall, based on the current patient recruitment rate, topline data from this Phase 2a study are expected to be available in Q1 2024.
Lisa Anson, Chief Executive Officer, Redx Pharma, commented, “We are pleased to be actively recruiting our Phase 2a IPF study in both Europe and the US, putting us in a position to report topline data from both the 12-week and 28-day cohorts in Q1 2024. We expect our ongoing non-clinical programme to provide the data during 2023 to address the FDA request and support longer term dosing in the US. We have strong capabilities in creating next-generation products – as shown by our discovery of a next-generation BTK inhibitor – and we are excited about the potential of our next-generation ROCK2 inhibitor, RXC007, to treat a range of fibrotic conditions where there exists a significant unmet medical need.”
ROCK2 inhibition is now a commercially validated target with potential in multiple disease areas, following the recent FDA approval and launch of the first drug with this mechanism of action for the treatment of chronic graft versus host disease (cGvHD). In addition to the ongoing clinical development plan in IPF, Redx has also generated consistently supportive preclinical data that highlights the broad potential of next-generation ROCK2 inhibitors across a number of fibrotic indications where there remains a significant unmet need. Redx recently presented proof-of-concept data at the International Colloquium on Lung and Airway Fibrosis (ICLAF)[1] that detailed development work in immune mediated models of cGvHD, where the underlying disease mechanisms that drive pathology in the model show similarities to those observed in the lung pathology of auto-immune driven fibrotic diseases such as systemic sclerosis and interstitial lung disease (ILD). Furthermore, encouraging data from an ongoing collaboration with the Garvan Institute of Medical Research, presented at the Antifibrotic Drug Development Summit (AFDD)[2], has shown the potential of Redx’s ROCK2 inhibitors in cancer-associated fibrosis, such as that seen in pancreatic cancer. Redx plans to provide updates on further development as appropriate.
[1] https://www.redxpharma.com//srv/htdocs/wp-content/uploads/2022/10/RXC007_ICLAF_Poster_2022-10-01_FINAL-1.pdf
[2] https://www.redxpharma.com//srv/htdocs/wp-content/uploads/2023/02/RXC007_ROCK2_AFDD_11Nov2022_FINAL.pdf
