Futura Medical PLC MED2002: Breakthrough Results in $5 billion Market (1378J)
September 07 2016 - 1:01AM
UK Regulatory
TIDMFUM
RNS Number : 1378J
Futura Medical PLC
07 September 2016
For immediate release 7 September 2016
Futura Medical plc
("Futura" or "the Company")
MED2002: Breakthrough Results in $5 billion Market
Futura Medical plc (AIM: FUM), the innovative healthcare company
focused on advanced transdermal technology, is pleased to announce
headline results from its pivotal efficacy study of MED2002, the
Company's novel gel for the treatment of erectile dysfunction
("ED"). The results of the study show that MED2002 has achieved its
primary endpoint and successfully demonstrated efficacy, safety and
speed of onset.
The study comprised a total of 232 randomised males and it
measured, as its primary endpoint, improvement in the erectile
function ("EF") domain score of the International Index of Erectile
Function ("IIEF"), the scoring system used for the approval of PDE5
inhibitors such as Viagra(R) . The study was of a
placebo-controlled, double blind, home use, crossover design.
The study, which included mild, moderate and severe ED patients,
achieved its primary endpoint in showing a statistically
significant improvement in erectile function (p-value of 0.0132) in
the EF domain score averaged across all groups of males when using
MED2002 compared with placebo.
The results in the mild ED patient group were highly
statistically significant with a p-value of 0.0001 on MED2002
compared with placebo, with nearly twice as many males reporting a
clinically relevant improvement in the EF domain when using MED2002
compared with placebo. The study used one dosage, 0.2% w/w glyceryl
trinitrate gel, and Futura will consider whether the use of a
higher dosage could provide further measurable benefit to the
moderate and severe ED sufferers.
The speed of onset of action of MED2002 was rapid, partly
reflecting the method of application with the gel being applied
directly to the penis. 82% of patients with mild ED had an onset of
action within 10 minutes and in 54% of mild ED patients onset was
within 5 minutes. This rapid onset of action means that MED2002 has
the potential of being the world's fastest-acting treatment for
ED.
No major safety concerns were identified. No serious adverse
events or serious adverse reactions were recorded and there were no
drop-outs from the study owing to side-effect issues. This safety
profile suggests that MED2002 could be positioned as a consumer
healthcare product at an appropriate dosage in addition to being a
prescription-based medicine.
The safety profile also supports MED2002's use in a significant
area of unmet need in ED: the estimated 7.5% of ED sufferers who
cannot be prescribed PDE5 inhibitors due to contraindications with
other medicines taken by them.
The results from this study will form the basis of the
commercialisation strategy for MED2002, which shares the same
active ingredient as the Company's novel erectogenic condom,
CSD500.
A more detailed analysis of the study results is being carried
out over the next several days and further details are expected to
be provided with the Company's half year financial results, to be
issued on Tuesday 13 September 2016.
James Barder, Futura's Chief Executive, commented: "I am
delighted that our novel gel for the treatment of erectile
dysfunction, MED2002, has met its primary endpoint by showing
efficacy. The headline data from the study indicate that we have a
breakthrough ED product that is not only effective but may also
combine potentially the world's fastest speed of onset for an ED
treatment with a very favourable safety profile. We will carry out
further analysis of the results in the next few days and are very
excited by the commercial potential of this product."
It is expected that further details of the MED2002 study results
will be announced with the Company's half-year financial results on
13 September 2016. An analyst briefing will take place at 10.00am
on the day of the results at the offices of Buchanan, 107
Cheapside, London EC2V 6DN.
To listen to a live webcast of the analyst briefing, please log
on to the following web address approximately 5 minutes before
10.00am on the day of results, 13 September 2016:
http://vm.buchanan.uk.com/2016/futuramedical130916/registration.htm.
For further information please contact:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 685 670
Email to: james.barder@futuramedical.com www.futuramedical.com
N+1 Singer (Nominated Adviser
and Broker)
Aubrey Powell / Liz Yong Tel:+44 (0) 20 7496 3000
For media enquiries please contact:
Buchanan
Mark Court / Sophie Cowles / Tel: +44 (0) 20 7466 5000
Stephanie Watson
Notes to Editors
Futura Medical plc
Futura Medical is a pharmaceutical group that develops
innovative products for consumer healthcare. The Company is
developing a portfolio of products and its strategy is to license
their manufacture and distribution to major pharmaceutical and
healthcare groups.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
This information is provided by RNS
The company news service from the London Stock Exchange
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