16 November 2016
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce the outcome of the detailed analysis of the results of the recent breakthrough clinical study of MED2002, its topical gel for erectile dysfunction (“ED”), and to outline the Company’s strategy for the further development of the product following the Company’s recent fundraising.
Since the announcement of the clinical results on 7 September 2016, the Company has conducted extensive sub-analysis of the clinical data. The clinical study used one dosage of the active principle, 0.6mg of glyceryl trinitrate, and produced highly statistically significant results in the mild ED patient group.
The sub-analysis has also showed statistically significant results in the mild to moderate group and also suggests that an increased strength dose, 1.2mg of glyceryl trinitrate, may increase the gel’s efficacy especially in the moderate and severe ED patient groups.
All the existing oral medications for ED offer at least two dose strengths to treat the different levels of ED severity experienced by patients. Futura intends to adopt a similar treatment strategy to optimise MED2002’s potential commercial and therapeutic benefits.
In parallel with ongoing out-licensing negotiations, the Company is planning a further Phase III clinical programme for MED2002, which is expected to start recruiting patients next year. The programme will include two dosage strengths of MED2002’s active principle: 0.6 mg and 1.2mg of glyceryl trinitrate.
James Barder, Futura’s Chief Executive, commented: “We believe the strategy of including two dosages of MED2002 in the remaining clinical development program to potentially treat as wide a range of ED sufferers as possible will maximise the potential of this ground-breaking ED treatment.
“This strategy is also mindful that with MED2002’s rapid speed of onset and favourable safety profile, two dose strengths may unlock the great potential of an over the counter treatment in an indication for which only one in three affected men are prepared to go to a doctor to seek treatment. At the lower dosage, MED2002 could potentially address the over the counter market whilst the higher dose could be prescription only. We look forward to providing further updates on the trial next year.”
This announcement contains inside information.
For further information please contact:
Aubrey Powell / Liz Yong
Tel: +44 (0) 20 7496 3000
For media enquiries please contact:
Mark Court / Sophie Wills /
Stephanie Watson / Tilly Abraham
Tel: +44 (0) 20 7466 5000
Notes to editors:
About 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.