Futura Medical PLC Top Line Results from MED2005 Phase 3 study (2800W)

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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: [e-mail]

Tel: [phone]

Nominated Adviser and Sole Broker:

Liberum

Bidhi Bhoma/ Euan Brown/ Kane Collings

Tel: [phone]

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: [e-mail]

Tel: [phone]

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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December 10, 2019 02:00 ET (07:00 GMT)