ValiRx to work with Aptus on VAL301 clinical development plan
By Josh White
Date: Thursday 04 Jul 2019
(Sharecast News) - Clinical stage biotechnology company ValiRx announced on Thursday that its clinical team has signed an agreement to work with UK based clinical contract research organisation Aptus Clinical to effectuate a clinical development plan for 'VAL301', incorporating a phase 1 and 2 study design concept in endometriosis.
The AIM-traded firm said it would be working with Aptus on regulatory, technical and scientific areas, in order to bring VAL301 nearer to the clinic.
It described endometriosis as 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 were often described as "severe", and were associated with a decreased quality of life for young women.
The condition affected an estimated one in 10 women during their reproductive years, equating to approximately 176 million women worldwide, posing a high economic burden.
VAL301 was derived from the same active pharmaceutical ingredient as 'VAL201', which is currently in a phase 1 and 2 clinical trial where the compound had demonstrated safety, and had been well tolerated.
Those positive results would be used to strengthen the clinical application of the development programme.
ValiRx said pre-clinical studies indicated that treatment with VAL301 should not affect bone density or fertility - two of the major problems associated with current medical treatments for endometriosis.
The company said it intended to develop VAL301 as a non-invasive, effective and better tolerated treatment for the debilitating condition.
"Our agreement with Aptus represents an important stage in preparing the VAL301 compound for clinical study," said ValiRx chief executive officer Dr Satu Vainikka.
"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 and CEO of Aptus, added that his company was "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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