Publication of Positive MED2002 Clinical Data
04 January 2018
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce the publication of positive data from its Phase II clinical trial of MED2002* in erectile dysfunction (“ED”) in the peer-reviewed Journal of Sexual Medicine.
The article is available at this link: http://www.jsm.jsexmed.org/article/S1743-6095(17)31852-0/fulltext
The positive headline results of the Phase II trial were announced in September 2016 and showed that MED2002 has met its primary endpoint in showing a statistically significant improvement in erectile function in men with confirmed ED compared with placebo. The rapid onset of action of MED2002 means that it has the potential to be the world’s fastest-acting treatment for ED.
The Journal of Sexual Medicine article includes further data from the Phase II study including details of positive secondary outcome measures. These show significant improvements with MED2002 in orgasmic function (p=0.012), sexual desire (p<0.0001), intercourse satisfaction (p=0.0055) and overall satisfaction (p=0.001) compared with placebo. These improvements are in standard measures used in the International Index of Erectile Function questionnaire (IIEF). The IIEF is considered the ‘'gold standard' measure for efficacy assessment in clinical trials of ED. The data includes the result that 70% of participants on average experienced onset of erection within 10 minutes.
James Barder, Futura’s Chief Executive, said: “The publication of the Phase II clinical data in the leading, peer-reviewed scientific journal in sexual medicine underlines the robustness of our previously reported study and demonstrates the level of scientific interest in MED2002. The article, in the Journal of Sexual Medicine, reinforces our belief that MED2002 has the potential to be the world’s fastest-acting treatment for erectile dysfunction. MED2002 also has the potential to be a first-line treatment for ED patients who are unable to use existing oral treatments or who are seeking the benefits of greater spontaneity and intimacy through a fast acting treatment that doesn’t require pre-planning.
“We recently began the remaining clinical trial programme for MED2002 with a pharmacokinetic study, to be followed by two Phase III studies, the first of which is expected to begin in the first half of 2018.”
For any further information please contact:
|Futura Medical plc|
|James Barder, Chief Executive||Tel: +44 (0)1483 685 670|
|mail to: email@example.com||www.futuramedical.com|
|N+1 Singer (Nominated Adviser and Broker)|
|Aubrey Powell / Liz Yong||Tel:+44 (0) 20 7496 3000|
|For media enquiries please contact:|
|Mark Court / Sophie Wills / 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 and healthcare professionals. 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.
Journal of Sexual Medicine
The Journal of Sexual Medicine publishes multidisciplinary basic science and clinical research to define and understand the scientific basis of male, female, and couples sexual function and dysfunction. As an official journal of the International Society for Sexual Medicine and the International Society for the Study of Women's Sexual Health, it provides healthcare professionals in sexual medicine with essential educational content and promotes the exchange of scientific information generated from experimental and clinical research.
* MED2002 Product Nomenclature
MED2002 is the codename used by Futura in all public statements and on the Company website for the Company’s novel gel for erectile dysfunction. The brand name of Eroxon™ has also been registered for MED2002, which is currently in late stage clinical trials.
MED2002 contains the active pharmaceutical ingredient, glyceryl trinitrate (GTN). In the development history there are references to iterations including MED2000, 2001, 2002, 2003, 2004 and 2005 which are all proprietary formulations of GTN. The final ‘locked’ formulation for use in ongoing clinical trials is MED2005, the codename used for MED2002 in the recent published scientific literature.