RNS Number : 4015G
Minster Pharmaceuticals PLC
22 October 2008
For immediate release 22 October 2008
MINSTER PHARMACEUTICALS PLC
("Minster" or "the Company")
Positive results from Phase II trial of migraine with aura
Minster Pharmaceuticals plc (AIM: MPM), the drug development company specialising in
neurological and psychiatric disorders, is pleased
to announce positive results from its Phase II trial in Denmark of tonabersat in the
prevention of migraine with aura. The median number of
aura attacks was reduced by 68% (p=0.01) in patients receiving tonabersat when compared with
placebo. This result in the primary endpoint of
the study is both clinically and statistically highly significant.
A further primary endpoint showed a reduction in the number of migraine headache days.This reduction did not reach statistical
significance, probably owing to the small number of patients participating in the trial and,
it is thought, because some of the patients
suffered a type of migraine aura that is not followed by headache.
The results also showed statistically significant effects on some of the secondary
endpoints including the number of attacks of migraine
headache and the number of auras followed by any headache. All secondary endpoints were
numerically in favour of tonabersat compared with
placebo.
Migraine with aura affects around 30 per cent of migraine sufferers and is a type of
migraine in which the headache is preceded by
symptoms such as visual disturbances and abnormalities of speech and hearing. These aura
symptoms are generally recognised as being
difficult to treat with existing medications.
A total of 31 patients completed the Phase II trial, which was conducted at the Danish
Headache Centre at Copenhagen's Glostrup
University Hospital. The principal investigator in the trial was Professor Jes Olesen, the
Danish Headache Centre's Director and one of the
world's leading authorities on headache.
Under the trial's cross-over design, patients took either tonabersat or placebo once a day
for a three-month period after which the
treatment regime was reversed such that those initially on tonabersat received placebo and
vice versa. The tonabersat dosage was 20mg a day
for the first two weeks, increasing to 40mg a day for the subsequent 10 weeks.
In line with previous experience, tonabersat was generally well tolerated by patients.
It is expected that the detailed results of the trial will be published by Prof Olesen`s
group in a peer-reviewed article in a leading
international journal.
Tonabersat is the leading compound in an exciting new class of selective drugs known as
neuronal gap junction blockers, which offer the
potential to prevent the onset of migraine as a preferred alternative to acute treatment.
Minster is currently conducting the 500 patient TEMPUS trial of tonabersat in prevention
of migraine in the US and Canada. This Phase
IIb trial is fully enrolled and results are expected in the first quarter of 2009.
Professor Jes Olesen, the principal investigator in the trial and Director of the Danish
Headache Centre, said: "This is the first time
for more than 30 years that a drug designed specifically for migraine prevention shows
significant efficacy. There is a huge need for better
preventives, so these trial results are very encouraging. It is clear that tonabersat has very
real potential in the preventive treatment of
migraine."
Paul Sharpe, Minster Pharmaceuticals' Chief Executive Officer, said: "The very positive
results from this Phase II trial in migraine
with aura reinforce our confidence in the potential of tonabersat. These results represent a
significant advance in our overall programme,
which we are well funded to deliver, to establish tonabersat as the treatment of choice for
prevention of migraine attacks. We look forward
to the results of the TEMPUS trial of tonabersat in the wider migraine population, which is on
track to report out in Q1 2009."
For further information:
Minster Pharmaceuticals plc Tel: +44 (0) 1799 506623
Paul Sharpe, Chief Executive Officer
Robert Aubrey, Chief Financial Officer
Buchanan Communications Tel: +44 (0) 20 7466 5000
Mark Court / Rebecca Skye Dietrich / Catherine
Breen
Nomura Code Securities Limited Tel: +44 (0) 20 7776 1200
Chris Collins
Richard Potts
Notes for editors:
About Minster Pharmaceuticals plc
Minster Pharmaceuticals is a drug development company focussed on neurological and
psychiatric disorders. Its principal pipeline assets
are tonabersat, under development in the preventive treatment of migraine, and sabcomeline in
schizophrenia. Worldwide rights to both
compounds were acquired from GlaxoSmithKline and the compounds benefit from comprehensive
safety tolerance data as a result of investment by
GSK.
Tonabersat is the leading compound in an exciting new class of selective drugs designated
as neuronal gap junction blockers and offers
the potential to prevent the onset of migraine as a preferred alternative to acute treatment.Sabcomeline, a muscarinic partial agonist, has
potential in the treatment of chronic schizophrenia.
Minster's near-term focus is on the development and commercialisation of its current
pipeline. Its medium term strategy is to leverage
the anticipated cashflows from the current pipeline by in-licensing further compounds with the
ultimate objective of creating a substantial
and highly efficient drug development enterprise focussed on the central nervous system.
Minster joined the AIM market in February 2005 and trades under the symbol MPM. For
further information please visit
www.minsterpharma.com .
This information is provided by RNS
The company news service from the London Stock Exchange
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