REG - Futura Medical PLC - Commencement of MED2002 Clinical Trial <Origin Href="QuoteRef">FUM.L</Origin>

Futura MedicalAnnouncement

16/07/2015 12:33

RNS Number : 1542R
Futura Medical PLC
25 June 2015
 For immediate release
25 June 2015
Futura Medical plc
("Futura" or "the Company")
Commencement of MED2002 Clinical Trial 
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that it has received all of the regulatory approvals needed to begin its pivotal efficacy trial of MED2002, the Company's topical gel for the treatment of erectile dysfunction ("ED"), and that pre-screening of patients has commenced.
The design of the trial has been modified to include a larger number of patients, which will increase the statistical robustness of the outcomes from the study. A total of 192 patients are now expected to take part in the trial, which is taking place in the UK in London. 
The primary end point of the trial is the efficacy of MED2002 in male subjects self-diagnosed with ED using the erectile function domain of the International Index of Erectile Function (IIEF). The IIEF is a well validated measure of erectile function and was used for the approval of PDE5 inhibitors, such as Viagra. Secondary endpoints in the trial will include the speed of onset.
The trial will be of a randomised, placebo-controlled, double blind, home use, crossover design. The increased number of patients means that the study is expected to report in H1 2016, compared with earlier guidance of Q4 2015. Further recruitment sites within the EU have been identified and, pending satisfactory country specific regulatory and ethical approvals, it may be possible to accelerate patient recruitment and thereby achieve an earlier reporting date. Further updates on the trial's progress will be provided as appropriate.
Assuming that this trial is successful, it is expected to be one of two pivotal trials required for the regulatory filing of the product. Futura has received interest from potential commercial partners for MED2002 and the commercialisation strategy, including design of the second pivotal trial, will be decided following the results of the current trial. 
James Barder, Futura's Chief Executive, commented: "We are delighted that this clinical study of MED2002 has now commenced in the UK. We are using an enhanced trial design which includes an increased number of patients to improve the power of the statistical analysis in this pivotal study."
For further information please contact:
Futura Medical plc

James Barder, Chief Executive
Tel: +44 (0) 1483 685 670
Email to: james.barder@futuramedical.com
www.futuramedical.com
N+1 Singer (Nominated Adviser and Broker)

Aubrey Powell / Tom Smale - Corporate Finance 
Tel:+44 (0) 20 7496 3000
For media enquiries please contact: 

Buchanan 

Mark Court / Sophie Cowles / Stephanie Watson
Tel: +44 (0) 20 7466 5000
Notes to Editors
Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.
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 company news service from the London Stock Exchange
  END
MSCBRGDLUGDBGUS