VAL401 improves quality of life

ValiRx is a clinical-stage biopharmaceutical company focused on the development of therapeutics for the treatment of cancer, associated biomarkers and companion diagnostics. The company’s two leading assets are in clinical trials: VAL201 (Phase I/II) – a peptide for advanced prostate cancer and potentially other hormone- induced indications; and VAL401 (Phase II) – a reformulation of risperidone for lung cancer. Following previous announcements on safety, tolerability and improvement in overall survival, VAL has disclosed further clinical analysis of its Phase II data with VAL 401, that demonstrate a positive impact on patients’ quality of life.

• Strategy:  ValiRx operates as a virtual business, out-sourcing most of its activities. The core strategy is to develop its therapeutic assets through the clinical pathway and seek a partner/licensing deal to complete the development programme and regulatory submissions to commercialise the products.
• Quality of life:  VAL401 achieved an overall response rate of 60% and improved the quality of life in patients with late-stage lung cancer. There was some evidence to show that VAL401 improves the disease symptoms, suggesting a palliative effect, and could be a good candidate for a combination study.
• Next steps:  Safety and tolerability of VAL401 has been confirmed in late stage patients affected by non-small cell lung cancer. With this new data showing an increase of the quality of life, management is currently preparing regulatory works for the next stage of clinical testing.
• Risks:  New and/or first-in-class drugs carry the risk that they might fail in clinical trials. However, the substantial safety history of the active ingredient in VAL401 and the consistent safety record in the VAL201 trial mitigate these risks. More capital will be needed to further its proprietary assets along the value chain.
• Investment summary:  The market has failed to recognise the potential of ValiRx, fretting more about the need for more capital to advance its clinical programmes than taking a rational view of the likely success of its clinical candidates. Given the clinical progress seen to date, the company is likely to be attracting the attention of potential commercial partners and/or institutional investors in order to achieve the true value of its assets.