Futura Medical to Present on new Impedance Testing Data for MED2005 for the Treatment of Erectile Dysfunction at the 21st ESSM Congress and Host Advisory Meeting
28 January 2019
Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical company developing a portfolio of innovative products for sexual health and pain relief, today announces that it will be presenting at the 21st Congress of the ESSM, on 14-16 February 2019, at Cultural and Congress Centre Cankarjev Dom, Ljubljana, Slovenia.
Futura's presentation will include new safety data relevant to sexual partners on its lead product MED2005, a topical glyceryl trinitrate ("GTN") gel for the treatment of erectile dysfunction ("ED"). Futura will also host its second Scientific Advisory Meeting in Slovenia with high profile European Key Opinion Leaders ("KOLs") in the field of ED.
Tim Holland, Director of Clinical Development at Futura Medical, will be presenting a poster entitled "Establishing the safety profile in sexual partners of a new topical glyceryl trinitrate gel for the treatment of erectile dysfunction" on Thursday 14 February at 15.30 CET. The presentation will be part of the "Male sexual dysfunction: medical treatment" poster session held in Foyer 1, Floor 1.
In addition to the previously reported Phase 2a and pharmacokinetic data presented, which indicated that MED2005 will be likely to have a favourable safety profile in female partners, Futura Medical will present supporting evidence regarding the topical safety of MED2005, based on in vitro impedance testing concluded in late 2018.
A key safety and regulatory concern with topical treatments is whether or not they impact the barrier qualities of the skin, especially if they use harsh "skin penetration enhancers" (which are sometimes used to aid absorption), as this may increase risk of sexually transmitted infections (STIs). MED2005 contains glyceryl trinitrate and is formulated with Futura's patented Dermasys® system which contains no aggressive skin penetration enhancers.
Impedance testing was conducted to measure the potential disruption to cadaveric human epidermal tissue, compared to two commercially available lubricants used for sexual intercourse. Results showed no significant difference in impedance between MED2005 and the two lubricants. These data are strongly suggestive that there is likely to be no increased risk of STIs being transferred to sexual partners, as a result of disruption to local tissue, when using MED2005 compared to the two lubricants also tested.
Results of the 232 patient Phase 2a study, which was reported in 2016 and measured the adverse events recorded in female partners following the application of 0.2% MED2005 to the penis before intercourse, demonstrated that out of 1,003 intercourse events, only four instances of mild side effects were seen in sexual partners which were considered to be related to the product. There were two cases of headache and one case of nasopharyngitis and one case of vulvovaginal pruritis. One case of vulvovaginal pruritis was also noted in placebo
In addition, the pharmacokinetic study measured GTN absorption by tandem mass spectrometry on penile swabs taken 5 minutes after administration of 0.8% MED2005 to the glans penis. Results demonstrated a rapid rate of absorption through the penis leaving a relatively low GTN residue on the penis at 5 minutes; this provides further reassurance that there is likely to be minimal risk of transference of GTN to the sexual partner during intercourse.
A Phase 3 study ("FM57") is underway to assess efficacy and long-term safety of MED2005 at doses of 0.2-0.6% in approximately 1,000 patients with mild, moderate or severe ED across nine countries in Central and Eastern Europe. Recruitment into the Phase 3 study remains on track, with headline data expected by the end of 2019.
James Barder, Chief Executive Officer of Futura Medical said: "Erectile dysfunction has a significant negative effect on the quality of life, relationships and overall wellbeing of sufferers and their partners. One in six men is estimated to experience some form of ED in their lives1, yet there have been no new, globally-approved, clinical treatments for nearly two decades. These data give us great confidence in the future of MED2005 as a safe and fast-acting new treatment option for ED. We believe MED2005 has the required efficacy, speed of onset and favourable safety profile consistent with an over-the-counter as well as a prescription use therapy.
"We also look forward to hosting our second Advisory Panel meeting to discuss this meaningful data and the on-going development and educational programme for MED2005 with prominent European Key Opinion Leaders."
Futura Medical will host an R&D Day in London for analysts and institutional investors on Monday 11 February 2019, which will feature a presentation from eminent Key Opinion Leader David Ralph, a world leading expert in erectile dysfunction and male infertility. The R&D Day will provide an opportunity to hear about the Company, its R&D strategy with a focus on its DermaSys® drug delivery technology and lead product MED2005.
For further information please contact:
Aubrey Powell/ Ben Farrow (Corporate Finance)
Tom Salvesen/ Mia Gardner (Corporate Broking)
Tel: +44 (0) 20 7496 3000
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Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Ellie Blackwell
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Notes to editors:
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® 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
About MED2005: Eroxon® - Topical treatment for erectile dysfunction (ED)
MED2005, which uses Futura's DermaSys® drug delivery system, is the development name for its topical glyceryl trinitrate ("GTN") gel. It has the potential to be a highly differentiated therapy for the treatment of men with ED, especially mild to moderate ED. MED2005's rapid onset of action means that it has the potential to become the world's fastest-acting treatment for ED, with a speed of onset of around five minutes. Viagra® and Cialis® which dominate the existing on-market ED therapies are taken orally and do not take effect for at least 30 minutes and typically one hour or more2. Speed of onset and method of administration of MED2005 also help restore spontaneity and intimacy. Importantly, MED2005 may also be appropriate for ED sufferers on nitrates and other drugs that are contraindicated for use with phosphodiesterase-5-inhibitors ("PDE5Is") such as Viagra® and Cialis® and other existing oral ED treatments.
Note 1: Sources, Shabsigh R et al, J Urol 2005; vol. 174, 662-667
EMEA & Withdrawal assessment report for Viagra, 2008
Note 2: US patient information for Viagra® and Cialis®