Futura Medical PLC Positive data from MED2002 PK study (0098M)
April 25 2018 - 1:01AM
UK Regulatory
TIDMFUM
RNS Number : 0098M
Futura Medical PLC
25 April 2018
For immediate release 25 April 2018
Futura Medical plc
("Futura" or the "Company")
Positive data from MED2002 PK study
Futura Medical plc (AIM: FUM), the innovative healthcare company
focused on advanced transdermal technology, is pleased to announce
positive data from its pharmacokinetic ("PK") study FM58 of
MED2002, the Company's topical gel for erectile dysfunction ("ED").
MED2002 contains glyceryl trinitrate ("GTN") as its active
ingredient.
The PK study, which commenced in November 2017, evaluated the
doses of 0.2%, 0.4%, 0.6% and 0.8% GTN to assess their suitability
for maximising efficacy in the treatment of ED ahead of the two
Phase III studies being planned by the Company for MED2002.
The highly encouraging results confirm that increasing the GTN
dose beyond 0.2%, which was used in the successful Phase IIa study
which reported top-line findings in September 2016, will result in
broadly dose-related higher concentrations of GTN in the
bloodstream. This supports the Company's strong belief that the
higher dose forms of MED 2002 should improve efficacy, particularly
in the more severe cases of ED.
Strongly positive results were also seen in the other key
objectives of the study. GTN demonstrated a rapid rate of
absorption and was first detected in blood plasma in 4-5 minutes,
reaching peak levels in the bloodstream within 10-12 minutes for
all doses. These findings are important firstly as they underline
the effectiveness of the DermaSys(R) transdermal technology, and
also as they are consistent with a product that has shown a rapid
onset of action in the Phase IIa study. This is a key
differentiator to other ED products on the market as, when compared
with PDE5 inhibitors such as Viagra(R) and Cialis(R) which are
taken orally and do not take effect for at least 30 minutes and
typically one hour or more(1) , MED2002 would allow far greater
spontaneity between application and sexual intercourse.
In addition the study also measured the amount of GTN remaining
after 5 minutes of the highest dose being applied to the penis. The
study saw a rapid rate of absorption through the penis leaving a
low GTN residue on the penis at 5 minutes. By applying a 0.8% dose,
the study provides reassurance that there is likely to be minimal
risk in transference of GTN to the sexual partner during
intercourse, even at the higher doses. This finding also supports
the side effect profile seen in the Phase IIa study where only
four, mild side effects were seen in sexual partners out of 1,003
sexual intercourse attempts.
The PK study also demonstrated that the doses of GTN were well
tolerated by the subjects. Adverse events reported were generally
mild and at an acceptable level, even at the highest dose.
Importantly, the incidence of headache, a known adverse event of
GTN, did not increase significantly at the higher doses. This data
compares favourably with the 0.2% dose where mild headaches
reported previously had shown to occur in patients in less than 2%
of intercourse attempts in the Phase IIa study.
Futura is pleased to confirm that it has demonstrated that the
blood plasma concentrations of GTN of 0.2%, 0.4% and 0.6% fall
within the plasma concentrations of the chosen US reference
product, Nitrostat(R) , which is used to treat angina. The total
amount of GTN appearing in the bloodstream was lower than
Nitrostat(R) for 0.2%, 0.4% and broadly equivalent at 0.6%.
The Board is reviewing the implications of the detailed study
data with regard to the planning of the Phase III studies for
MED2002. Futura expects to make a further announcement on this
shortly.
James Barder, Chief Executive of Futura Medical, said: "We are
delighted to report the excellent data from our latest PK study for
MED2002. The results show the effectiveness of our DermaSys(R)
transdermal technology and demonstrate the potential of MED2002 as
a rapid and safe treatment option for erectile dysfunction. We look
forward to taking these excellent, supportive results into our
future clinical programme."
1. US patient information for Viagra(R) and Cialis(R)
For any further information please contact:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0)1483 685
670
mail 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 Wills 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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