Futura Medical PLC MED2002: PK Study Commences (7852X)
29 November 2017 - 6:00PM
UK Regulatory
TIDMFUM
RNS Number : 7852X
Futura Medical PLC
29 November 2017
For immediate release 29 November 2017
Futura Medical plc
("Futura" or "the Company")
MED2002: PK Study Commences
Futura Medical plc (AIM: FUM), the innovative healthcare company
focused on advanced transdermal technology, announces that
recruitment has commenced for the Company's pharmacokinetic ("PK")
study of MED2002, Futura's novel gel for the treatment of erectile
dysfunction ("ED").
Data from the PK study in 40 healthy subjects, which represents
the initial step in Futura's Phase III programme for MED2002, will
assist in determining the dosages to be used in two Phase III
studies, which will begin next year as soon as practicable after
the completion of the PK study.
The PK study will check the tolerance of subjects to a range of
doses of MED2002 including higher doses than the dose used in the
earlier efficacy study, the results of which were announced on 7
September 2016 and will also compare MED2002's safety profile
against an approved angina treatment with the same active
pharmaceutical ingredient.
The PK study will enable the exclusion of unacceptably high
doses in the Phase III studies and provide additional safety data
to support the proposed US regulatory pathway of a 505(b)(2)
filing. Subject enrolment in the PK study is expected to be
completed in early Q1 2018 and the results are expected to be
available by the end of Q1 2018.
James Barder, Futura's Chief Executive, said: "The start of this
PK study is of great significance for Futura as it marks the
beginning of our Phase III programme for MED2002, our novel gel for
the treatment of erectile dysfunction. By pre-screening
formulations at a number of dosage strengths, the PK study will
enable the Phase III studies to be run as expeditiously and cost
effectively as possible.
"MED2002 has huge potential as a prescription medicine. This
potential was highlighted by recent market research announced in
October 2017, which found that more than 60 per cent of physicians
in the US consider MED2002 to be an improvement over current ED
therapies."
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
/ Stephanie Watson 5000
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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