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Futura Medical PLC
28 October 2019
New Clinical Data Provide Additional Validation for the Safety
and Efficacy of Futura Medical's Topical MED2005 in the Treatment
of Erectile Dysfunction
Abstracts presented at the 20(th) Annual Fall Scientific Meeting
of the Sexual Medicine Society of North America (SMSNA) report
rapid absorption and onset of action with favorable short-term
safety for female partners
Guildford, England - October 28, 2019 -- 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, today announced that data
reported in two abstracts at SMSNA add to the growing body of data
supporting the safety and efficacy of the Company's MED2005 topical
gel for the treatment of erectile dysfunction (ED). In addition to
demonstrating dose-proportional increases in penile blood flow
following application of MED2005, the data also show that MED2005
has a good safety profile in female partners who are exposed to
MED2005 through intercourse. SMSNA 2019 took place in Nashville,
October 24-27.
While oral PDE5 inhibitors have provided significant benefits to
many men with ED, these medications have limitations and up to half
of patients discontinue treatment within 12 months of therapy
initiation. Lorraine Grover, Psychosexual Nurse Specialist at The
London Clinic explains "ED is often seen as strictly a male
disease, but the condition often has a significant impact on
partners' quality of life and can put additional pressure on
partnerships. The data presented at SMSNA are encouraging and
support the continued evaluation of MED2005 as a potential new ED
treatment option for men who can't tolerate or don't respond to
PDE5 inhibitors or who prefer a more rapid onset of action that
enables greater spontaneity in their sexual relationships."
Current estimates suggest that ED disrupts the lives of at least
one in five men globally, affecting the sexual and emotional health
of approximately 27 million men and their partners in the United
States alone. MED2005, a topical gel formulation of nitroglycerin
applied directly to the penis by the male or his partner, works
rapidly to help achieve and maintain an erection, and has
significant potential as an innovative ED therapy that can overcome
the medical and psycho-emotional limitations of PDE5i. A Phase 3
study is currently ongoing to assess the efficacy and safety of
MED2005 at doses of 0.2-0.6% in 1,000 patients and their female
partners.
"The data presented today add to the growing body of data
supporting the clinical and commercial potential of MED2005," said
James Barder, Chief Executive Officer of Futura Medical. "In
previous studies MED2005 has been shown to significantly improve
orgasmic function, intercourse satisfaction and overall
satisfaction. Today's data provide evidence that these benefits may
be achieved with a good partner safety profile. We believe that
MED2005's fast-acting, topical formulation combined with the
growing body of clinical evidence demonstrating efficacy and
safety, make this innovative ED therapy an ideal alternative
product. Additionally, these data further validate the broad
potential of our DermaSys(R) advanced transdermal delivery system
to enable novel treatment approaches that have improved safety and
efficacy profiles compared with other modes of delivery."
SMSNA Data Presentations
Ultrasound Doppler Measurements of Penile Blood Flow as a
Predictor of Clinical Efficacy(1)
(Abstract #114)
This placebo controlled, double-blind, dose ranging, crossover
study evaluated the effect of escalating doses of MED2005 on
erectile function as assessed by ultrasound Doppler measurement of
blood flow within the penile cavernosal arteries. The study was
conducted in 15 healthy, adult men and evaluated doses of 0.01,
0.075, 0.25 and 0.6 mg of MED2005. Significant differences in
penile blood flow were noted only in the 0.6mg dose although 0.25mg
showed some directional improvement. All doses were well tolerated
and there was no clear evidence of headache as a drug related
adverse event. No fall in blood pressure or symptoms associated
with hypotension were reported. On this basis the 0.6mg (0.2%) dose
was chosen for a Phase 2a) study.(2) Results of that study
demonstrate that ultrasound Doppler measurements of penile blood
flow is a useful predictive Phase 1 pharmacodynamic tool in dose
optimization, and correlates well with clinical efficacy.
Establishing the safety profile in sexual partners of a new
topical nitroglycerin gel for the treatment of erectile
dysfunction(3)
(Abstract #031)
This study evaluated the safety of MED2005 in female partners of
232 men who participated in a Phase 2a study.(2) Adverse events
were recorded in female partners following the application of 0.2%
MED2005 (n=229) to the penis before intercourse. A 6-10
pharmacokinetic study was conducted to assess absorption of 0.8%
MED2005 to the penis (n=10). Disruption of the epidermal membrane 2
hours after administration of MED2005 was evaluated on epidermal
tissue from cadavers and compared with commercial lubricants.
Results show that in over 1003 intercourse events, only 4 mild AEs
in females were related to their partners' MED2005 treatment (two
cases of headache and one case each of vulvovaginal pruritus and
nasopharyngitis). Five minutes after application, an average of 27%
of MED2005 remained on the penis, indicating absorption of 73% of
the gel. Linear input rates predicted that virtually no MED2005
would remain on the penis 6-10 minutes after application. There was
no significant difference between MED2005 and commercial lubricants
on integrity of human epidermal membranes compared to KY warming
(p=0.58) and Astroglide (p=0.30). The study authors conclude that
MED2005 has a favorable short-term safety profile in female
partners. Furthermore, the data suggest that MED2005 shows no
increased potential for sexually transmitted infection risk in
partners compared to commercial lubricants.
References
1. Holland T, James K, Ultrasound Doppler measurements of penile
blood flow as a predictor of clinical efficacy. Abstract #114.
Presented at the 20(th) Annual Fall Scientific Meeting of the
Sexual Medicine Society of North America. October 24, 2019.
2. Ralph DJ, Eardley I, Taubel J, Terrill P and Holland T.
Efficacy and safety of MED2005, a topical glyceryl trinitrate
formulation, in the treatment of erectile dysfunction: a randomized
crossover study. J Sex. Med 2018;15:167-175.
3. Holland T, James K, Armstrong I, Establishing the safety
profile in sexual partners of a new topical nitroglycerin gel for
the treatment of erectile dysfunction. Abstract #031. Presented at
the 20(th) Annual Fall Scientific Meeting of the Sexual Medicine
Society of North America. October 26, 2019.
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
For US media enquiries please contact:
Lazar FINN Partners
Erich Sandoval, Media Strategist
Email: esandoval@lazarpartners.com
Tel: +1 212-867-1762
For European media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
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 optimized 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 commercialization
strategies are designed to maximize product differentiation and
value creation whilst minimizing risk.
In a Phase II study for MED2005 announced in September 2016 the
speed of onset of action of, 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.
The first European Phase 3 study for MED2002, referred to as
"FM57", is a 1,000 patient, dose-ranging, multi-center, randomized,
double blind, placebo-controlled, home use, parallel group study of
MED2002 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment
of erectile dysfunction with an open label extension. FM57 is
progressing on track, with headline data expected by the end of
2019.
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 news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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