Phase I/II Study Design Concept in Endometriosis

ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the Company’s clinical team has signed an agreement to work with Aptus Clinical Ltd (“Aptus”), the UK based, clinical Contract Research Organisation (“CRO”), to effectuate a clinical development plan for VAL301 incorporating a Phase I/II study design concept in Endometriosis. Aptus will be working with ValiRx on regulatory, technical and scientific areas, in order to bring VAL301 nearer to the clinic.

Endometriosis is a benign, oestrogen –dependent chronic condition, characterised by endometrial tissue growth outside of the uterus. Symptoms including heavy painful periods, pain with intercourse and infertility are often severe and are associated with a decreased quality of life for young women. The condition affects an estimated 1 in 10 women during their reproductive years, equating to approximately 176 million women worldwide, posing a high economic burden.

VAL301 is derived from the same active pharmaceutical ingredient as VAL201, which is currently in a Phase I/II clinical trial where the compound has demonstrated safety and has been well tolerated. These positive results will be used to strengthen the clinical application of the development programme. Pre-clinical studies indicate that treatment with VAL301 should not affect bone density or fertility, two of the major problems associated with current medical treatments for endometriosis. ValiRx intends to develop VAL301 as a non-invasive, effective and better tolerated treatment for this debilitating condition.

Dr Satu Vainikka, CEO of ValiRx, commented: “Our agreement with Aptus represents an important stage in preparing the VAL301 compound for clinical study. I look forward to VAL301’s future development and its potential to benefit women who suffer from this extremely painful condition”.

Dr Steve McConchie, Co-founder & CEO of Aptus, added: “We are delighted to have been selected by ValiRx to work on the development plan options for VAL301 in endometriosis. We look forward to exploring some innovative opportunities with the team in order to optimise the programme delivery timelines and progress this important potential treatment rapidly to patients".

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