Futura Medical Regulatory News (FUM)

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Futura Medical Announces First Patient Enrolled in European Phase 3 study of MED2002 for the Treatment of Erectile Dysfunction

31 October 2018

Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology currently focused on sexual health and pain, today announces that the first patient has enrolled in the first European Phase 3 study, ("FM57"), of MED2002, a topical glyceryl trinitrate ("GTN") gel for the treatment of erectile dysfunction ("ED"). 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: "We are pleased to announce the first patient enrolment in our first European Phase 3 trial with MED2002. This is an important milestone for Futura, building on the success of both the Phase 2 and PK data.

"Futura is now in a position to build value by progressing the development of MED2002 through its planned Phase 3 studies, and we are excited to be moving closer to bringing an innovative, highly differentiated ED product to market that could help the many ED patients whose needs are not met by current treatments."

FM57 is a dose-ranging, multi-centre, randomised, double-blind, placebo-controlled, home use, parallel group clinical trial of topically applied GTN and 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 include at least 60 centres across Central and Eastern Europe to ensure patients are recruited as quickly and efficiently as possible.

The Company's successful Phase 2 study ("FM53") achieved its primary clinical endpoint and demonstrated efficacy, safety and a rapid speed of onset in 0.2% GTN dose. Results of this study were published in a peer reviewed paper in The Journal of Sexual Medicine in February 2018. 

FM57's protocol has incorporated feedback received from potential commercial partners, opinion-leading physicians, US and EU regulatory agencies as well as the Company's learnings from FM53 to support the best chance of clinical success and to optimise the likelihood of subsequent regulatory approval as well as the commercial value. The Company's confidence in the outcome of the study is supported by the success of FM53 and the PK study results announced earlier this year, which demonstrated dose-dependent absorption and supports the potential for greater clinical efficacy of higher doses than 0.2% whilst maintaining patient safety and tolerability.

For further information please contact:

Futura Medical plc James Barder, Chief ExecutiveAngela Hildreth, Finance Director and COO

Email: Investor.relations@futuramedical.comTel: +44 (0) 1483 685 670 

Nominated Adviser and Broker:N+1 SingerAubrey Powell/ Jen Boorer/ Ben Farrow (Corporate Finance)

Tom Salvesen (Corporate Broking)Tel: +44 (0) 20 7496 3000

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Hollie Vile/ Ellie Blackwell

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 950 9144

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 MED2002: Eroxon® - Topical treatment for erectile dysfunction (ED)

MED2002, 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. MED2002'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 more1. Speed of onset and method of administration of MED2002 also help restore spontaneity and intimacy. Importantly, MED2002 may also be appropriate for ED sufferers on nitrates and other drugs that are contraindicated for 5 use with phosphodiesterase-5-inhibitors ("PDE5Is") such as Viagra® and Cialis® and other existing oral ED treatments.

Note 1: US patient information for Viagra® and Cialis®

Forward looking statements

This announcement may contain certain forward-looking statements. Whilst the Directors believe all such statements to have been fairly made on reasonable assumptions, there can be no guarantee that any of them are accurate or that all relevant considerations have been included in the directors' assumptions; accordingly, no reliance whatsoever should be placed upon the accuracy of such statements, all of which are for illustrative purposes only, are based solely upon historic financial and other trends and information, including third party estimates, and may be subject to further verification. These forward-looking statements are based on management's current expectations as of the date of this announcement and should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release. These statements involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any expectations expressed or implied by the forward-looking statements. These and other important factors, under the heading "Risk Factors" in the Company's recently issued circular to shareholders in relation to its proposed fundraising (available at https://www.futuramedical.com/archive/2018-GM-Notice-121118.pdf) and under the heading "Principal risks and uncertainties" in the Company's last annual report, could cause actual results to differ materially from those indicated by the forward-looking statements made in this announcement. Neither the Company nor its Directors makes any representation or warranty in respect of the accuracy, completeness or verification of the contents of this announcement.

James Barder, CEO, and Angela Hildreth, FD & COO arranged for the release of this announcement on behalf of the Company.