TIDMFUM
RNS Number : 2800W
Futura Medical PLC
10 December 2019
10 December 2019
Futura Announces Top Line Results from MED2005 Phase 3 study
-- In FM57, all arms met all primary endpoints against baseline,
showing strong efficacy, excellent safety, rapid speed of onset
-- However, in FM57, MED2005 did not meet primary endpoints versus placebo
-- Surprising but highly statistically significant, results
compared against baseline provides the company the possibility of a
simpler regulatory pathway, as a medical device
-- New patent application filed which has the potential, if
successful, to extend protection until 2039
Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical
company developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys(R) drug delivery technology and
currently focused on sexual health and pain, announces its top line
results from the European Phase 3 study, "FM57" of lead product,
MED2005 for the treatment of erectile dysfunction ("ED).
Efficacy
The Phase 3 study investigated the efficacy and safety of 0.2%,
0.4% and 0.6% glyceryl trinitrate ("GTN") doses of MED2005 in 1,000
mild, moderate and severe erectile dysfunction ("ED") patients in
Europe versus DermaSys alone. Patients being enrolled into the FM57
for the initial four weeks had to attempt intercourse on at least
four occasions in order to establish the severity of their ED known
as the 'baseline'.
All three primary co-primary endpoints (IIEF-EF, SEP2 and SEP3)
were achieved against baseline data for MED2005 and DermaSys in
addition to important, supporting secondary endpoints in terms of
efficacy, speed of onset, duration of action and patient meaningful
differences.
However, the placebo used in the study which was Futura's
proprietary transdermal DermaSys formulation also demonstrated
statistically significant and clinically meaningful top line
results meaning that FM57 did not meet primary endpoints versus
placebo. Whilst this placebo does not contain the active
pharmaceutical ingredient, GTN, used in MED2005, it uses the key
ingredients that constitute DermaSys' proven transdermal technology
and was shown to be as effective in the treatment of ED as the
active doses.
Safety and tolerability data were also highly positive, with no
serious adverse events recorded in any patients with a highly
favourable overall side effect profile across all doses against
baseline affirming data from the prior Phase 2a study.
Data demonstrated a statistically significant improvement in
erectile function across 'pooled' patient severities (mild,
moderate, and severe) of erectile dysfunction using 0.2%, 0.4% and
0.6% GTN doses and DermaSys against baseline with over 60% of all
patient's experiences meaningful difference in improvement of their
erections using industry standard assessment techniques recognised
and accepted by leading ED KOLs. Over 60% of patients saw a speed
of onset within 10 minutes of application, substantially faster
than sildenafil with significant benefits for spontaneous rather
than pre-planned sexual intercourse.
Next Steps
The surprising yet highly statistically significant results for
the DermaSys control arm (placebo) compared against baseline
provides the company with a new, potentially simpler regulatory
pathway for DermaSys as a medical device as compared with MED2005
as a drug, yet with strong clinically proven claims for the
treatment of erectile dysfunction. Moreover, and subject to
identifying a regulatory pathway, the Board believes this may
provide a faster route to market and a greater commercial
opportunity with the opportunity to provide a clinically proven
treatment for many patients currently contraindicated from using
existing medications such as nitrates and alpha blockers. The
Company has also filed a new patent application which has the
potential, if successful, to extend protection until 2039.
James Barder, Chief Executive Officer, Futura Medical said:
"While we are surprised that FM57 has not met the primary endpoints
versus placebo, we are excited that DermaSys alone has achieved
such statistical significance in meeting all the primary endpoints
against the baseline and key secondary endpoints using validated
and globally accepted measurement tools. We now believe this
supports the potential for a simpler route to regulatory approval
for the proprietary DermaSys formulation as a clinically proven
treatment for erectile dysfunction."
We will provide shareholders with an update on what we believe
will be a new simpler and expected lower cost regulatory pathway as
soon as possible."
Ken James, Executive Director and Head of R&D added. "It is
encouraging to see that the DermaSys formulation is highly
effective across all ED patient severities, despite MED2005 not
having met primary endpoints against the control arm. We believe it
has the potential to be a significant innovation in the $5.6
billion erectile dysfunction global market especially for patients
looking for a rapid speed of onset and spontaneity, with an
excellent adverse event profile."
Professor David Ralph, Consultant Urologist at University
College London and past president of the European Society of Sexual
Medicine commented on the results. "The efficacy of the DermaSys(R)
product is remarkable and approaches the efficacy of current first
line therapy but with significantly lower adverse events. With
topical application, it will be of particular appeal to patients
who want a fast onset of action. Lack of drug interactions with
prescription products will enable the product to be used with other
medications such as nitrates and other cardiovascular drugs. It can
also be used in conjunction with other ED products to improve
overall efficacy to patients. As such the product will be of great
interest to the medical community."
Dr Yacov Reisman, Consultant Urologist and president of the
European Society of Sexual Medicine commented on the results. "All
formulations tested in FM57, including the control product
DermaSys(R), have demonstrated positive and statistically
significant efficacy results against baseline data together with
excellent safety profile. The DermaSys(R) product will be of high
interest to the Medical Community for those patients who seeking a
very rapid onset of action and a very low side-effect profile. It
will likely find use in the substantial number of patients,
especially those with ED of a mild to moderate nature and those
patients who are contraindicated for use with existing
products."
Webcast
James Barder, Chief Executive Officer, and Ken James, Executive
Director and Head of R&D, will host a webcast to discuss the
data at 12pm GMT this afternoon, 10th December 2019, within the
Investor Centre section of the Futura company website at
www.futuramedical.com.
The information communicated in this announcement contains
inside information for the purposes of Article 7 of the Market
Abuse Regulation (EU) No. 596/2014.
S
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
Notes to editors:
About Futura's Phase 3 Study Design and Top Line Results
The Phase 3 study was a dose-ranging, randomised, double blind,
placebo controlled, home use, parallel group study evaluating
treatment of 1,000 patients with mild, moderate and severe ED
across nine countries and 60 centres in Central and Eastern Europe.
The study compared the efficacy of 0.2%, 0.4% and 0.6% GTN doses in
MED2005, a topically applied DermaSys formulation, against that of
placebo with an initial three-month, blinded, study period for each
patient. Highlights from that data are hereby reported.
The three co-primary endpoints used to demonstrate the efficacy
of MED2005 versus placebo in male subjects self-diagnosed with ED
are FDA preferred endpoints used in all recent FDA approvals for
PDE5i's (Cialis, Levitra and Stendra):
-- International Index of Erectile Function-Erectile Function
Domain Score (IIEF-EF): this is a score up to 30 whereby 10 or less
indicates severe ED, 11-17 indicates moderate ED, 18-25 indicates
mild ED and 26-30 is normal functioning.
-- Sexual Encounter Profile (SEP) questionnaire evaluating
sexual function where higher scores indicate better erectile
function, measuring the change during treatment in the percentage
of "yes" responses to SEP question two and three. SEP Q2 asks "Were
you able to insert your penis into your partners vagina?" and SEP
Q3 asks "Did your erection last long enough for you to have
successful intercourse?"
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company
developing a portfolio of innovative products based on its
proprietary, transdermal Dermasys(R) drug delivery technology.
These products are optimised for clinical efficacy, safety,
administration and patient convenience and are developed for the
prescription and consumer healthcare markets as appropriate.
Current therapeutic areas are sexual health, including erectile
dysfunction, and pain relief. Development and commercialisation
strategies are designed to maximise product differentiation and
value creation whilst minimising risk.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
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END
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