Futura Medical PLC Phase III efficacy study of MED2002 (1570M)
26 April 2018 - 4:00PM
UK Regulatory
TIDMFUM
RNS Number : 1570M
Futura Medical PLC
26 April 2018
For immediate release 26 April 2018
Futura Medical plc
("Futura" or the "Company")
Phase III efficacy study of MED2002
Futura Medical plc (AIM: FUM), the innovative healthcare company
focused on advanced transdermal technology, is pleased to provide
an update on the planned phase III trials for MED 2002, the
Company's topical gel for erectile dysfunction ("ED").
Following the excellent results from Futura's pharmacokinetic
("PK") study of MED2002 announced on 25 April 2018, the Company has
commenced preparatory work on the first Phase III efficacy trial
with a target of first patient dosed by the end of September
2018.
This first Phase III trial will be a dose ranging, multicentre,
randomised, double blind, placebo controlled, home use, parallel
group clinical trial of topically applied glyceryl trinitrate
("GTN"). This study ("FM58") will recruit approximately 1,000
patients with mild, moderate or severe ED and compare the efficacy
of 0.2%, 0.4% and 0.6% GTN doses of MED2002 against that of
placebo. The trial will be conducted throughout Eastern Europe with
a three-month study period for each patient.
Futura is confident that the positive PK data published this
month supports the decision to conduct Phase III studies at higher
doses than previously studied, and 0.6% GTN is the maximum dose
that would likely be considered suitable for the 505(b)(2)
regulatory pathway in the USA. Moreover, Futura believes the PK
study has improved the overall cost effectiveness and likely
success of the Phase III clinical studies, and enables those
studies to be run as efficiently as possible.
At present, Futura does not intend to carry out further
development work on the 0.8% GTN dose of MED2002 but, dependent on
the long-term objectives of potential commercial partners, we may
revisit this and other dose strengths in the future.
The Company's successful Phase IIa study ("FM53") previously
showed a statistically significant improvement in erectile function
for patients with mild and mild to moderate erectile dysfunction
using a 0.2% GTN dose versus placebo. By including doses up to
three times the level used in FM53, there is significant potential
for improved efficacy to be demonstrated including in the more
severe cases of erectile dysfunction.
Futura expects MED2002 will be well tolerated, even at the
highest dose of 0.6% GTN to be used in the Phase III trial, based
on the recently reported PK data where a low adverse effect profile
across all doses was observed (including at 0.8% GTN).
Depending on the speed of regulatory approval and patient
recruitment proceeding in line with reasonable expectations, we
would anticipate the following key milestones:
-- First patient dosed: by end of September 2018
-- Last patient dosed: by end of June 2019
-- Headline efficacy results: by end of December 2019
As part of the Phase III trial, long term safety data will be
recorded in compliance with international guidelines and reported
separately to the timelines outlined above.
James Barder, Chief Executive of Futura Medical, said: "We are
excited to be moving forward with the first Phase III trial of
MED2002. Following the excellent PK study results reported earlier
this week, we are now confident that the upcoming studies will be
run as efficiently and cost effectively as possible. The potential
for MED2002 as a safe, rapid and effective treatment for erectile
dysfunction is huge. We are pleased to report that discussions
regarding commercialisation are progressing and we look forward to
providing shareholders with a further update at the appropriate
time."
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 / Stephanie Tel: +44 (0)20 7466 5000
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 announcement contains inside information for the purposes
of article 7 of EU Regulation 596/2014
This information is provided by RNS
The company news service from the London Stock Exchange
END
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