Vantia Therapeutics today announces that its novel oral small molecule drug for the treatment of dysmenorrhoea (painful menstruation) has entered Phase II proof-of-concept trials. In addition, Vantia announces results of the successful Phase I trial of VA111913, which showed the product candidate to be safe and well tolerated.
The Phase II Proof of Concept study is a multi-centre, double-blind, placebo-controlled trial being conducted at sites in the UK and the US. The trial will recruit 128 women aged between 18 and 35 years with primary dysmenorrhoea including a consistent history of menstrual pain that limits daily activity and typically requires medication for relief. Subjects will be dosed with VA111913 and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of six days, beginning two days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle. Results are expected in H2 2010. Further details of the trial and of study site locations can be found on the website http://www.clinicaltrial.gov.
Dr Jim Phillips, CEO of Vantia Therapeutics, said, "Dysmenorrhoea affects a large number of women and there is currently no targeted therapy to treat the condition. VA111913 has been shown to normalise the contraction of smooth muscle and thus has the potential to directly target the cause of dysmenorrhoea by acting on the smooth muscle in the uterus wall. We believe this could offer an effective alternative to over-the-counter painkillers and 'off label' use of contraceptive drugs. The rapid progress of VA111913 underlines the quality of product candidates generated by our small molecule drug discovery capabilities and the ability of our team to drive them towards commercialisation."
The First-in-Human (Phase I) study comprised a single ascending dose phase, multiple ascending dose phase and a food effect study. Study treatment was generally well tolerated; all adverse events reported by subjects on active VA111913 treatment were mild and transient. No serious adverse events were reported during the study and no subject was withdrawn from the study due to an adverse event. There was no apparent dose-dependent effect on the nature or severity of adverse events reported. The pharmacokinetic profile of the product is supportive of twice daily dosing.
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