Vantia Therapeutics’ VA111913 Enters Phase II Proof-of-Concept Trials for Dysmenorrhoea Phase I Results Show VA111913 to be Safe and Well Tolerated
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
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were reported during the study and no subject was withdrawn from the study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.
Notes to Editors:
About Vantia Therapeutics:
Vantia Therapeutics is an emerging pharmaceutical company developing
novel, small molecule drugs targeting large, underserved medical markets. Its
rapidly advancing clinical pipeline includes VA106483 for nocturia in BPH
patients and VA111913 for dysmenorrhoea, product candidates which directly
target conditions that together affect many millions of people, are poorly
treated and represent billion dollar markets. Vantia was spun out from
Ferring Research Ltd in 2008 and its pipeline is driven by the proven small
molecule drug discovery and development capabilities of that unit and
Vantia’s experienced management team. Vantia’s strategy is to develop
candidates to Phase II proof-of-concept and then commercialise through
partnerships. The Company is well-funded and backed by specialist life
science investors MVM Life Science Partners, SV Life Sciences and Novo A/S.
http://www.vantiatherapeutics.com.
About VA111913 and dysmenorrhoea:
VA111913 is an oral small molecule drug candidate in Phase II clinical
development for prevention and treatment of dysmenorrhoea, a condition
characterized by abnormal contractions of the uterus during menstruation
causing severe pain. Dysmenorrhoea is associated with raised vasopressin
levels. VA111913 acts by blocking vasopressin 1a receptors in smooth muscle
in the uterus wall. VA111913 has been demonstrated in preclinical trials to
normalise smooth muscle contraction in response to vasopressin, thereby
offering the potential for it to be the first drug that directly targets the
cause of this condition in the uterus.
A Phase I trial with VA111913 has been completed and a Phase II proof of
concept study is currently underway. This is due to complete by H2 2010.
Dysmenorrhoea affects a large number of women for whom there are
currently no targeted therapies; treatments that are in common use however
include over-the-counter painkillers (e.g. naproxen or ibuprofen) or oral
contraceptives used ‘off-label’. It is estimated that the market opportunity
for a targeted drug for the prophylaxis and treatment of dysmenorrhoea is at
least
Contact details:
Vantia Therapeutics
Dr Jim Phillips, CEO +44-(0)238-076-3433
info@vantia.com +44-(0)7515-397176
Citigate Dewe Rogerson
Chris Gardner, Mark Swallow, Helena Galilee +44-(0)207-638-9571
vantia@citigatedr.co.uk
SOURCE Vantia Therapeutics