Phase III efficacy study of MED2002
26 April 2018
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to provide an update on the planned phase III trials for MED 2002, the Company's topical gel for erectile dysfunction ("ED").
Following the excellent results from Futura's pharmacokinetic ("PK") study of MED2002 announced on 25 April 2018, the Company has commenced preparatory work on the first Phase III efficacy trial with a target of first patient dosed by the end of September 2018.
This first Phase III trial will be a dose ranging, multicentre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically applied glyceryl trinitrate ("GTN"). This study ("FM58") 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 be conducted throughout Eastern Europe with a three-month study period for each patient.
Futura is confident that the positive PK data published this month supports the decision to conduct Phase III studies at higher doses than previously studied, and 0.6% GTN is the maximum dose that would likely be considered suitable for the 505(b)(2) regulatory pathway in the USA. Moreover, Futura believes the PK study has improved the overall cost effectiveness and likely success of the Phase III clinical studies, and enables those studies to be run as efficiently as possible.
At present, Futura does not intend to carry out further development work on the 0.8% GTN dose of MED2002 but, dependent on the long-term objectives of potential commercial partners, we may revisit this and other dose strengths in the future.
The Company's successful Phase IIa study ("FM53") previously showed a statistically significant improvement in erectile function for patients with mild and mild to moderate erectile dysfunction using a 0.2% GTN dose versus placebo. By including doses up to three times the level used in FM53, there is significant potential for improved efficacy to be demonstrated including in the more severe cases of erectile dysfunction.
Futura expects MED2002 will be well tolerated, even at the highest dose of 0.6% GTN to be used in the Phase III trial, based on the recently reported PK data where a low adverse effect profile across all doses was observed (including at 0.8% GTN).
Depending on the speed of regulatory approval and patient recruitment proceeding in line with reasonable expectations, we would anticipate the following key milestones:
- First patient dosed: by end of September 2018
- Last patient dosed: by end of June 2019
- Headline efficacy results: by end of December 2019
As part of the Phase III trial, long term safety data will be recorded in compliance with international guidelines and reported separately to the timelines outlined above.
James Barder, Chief Executive of Futura Medical, said: "We are excited to be moving forward with the first Phase III trial of MED2002. Following the excellent PK study results reported earlier this week, we are now confident that the upcoming studies will be run as efficiently and cost effectively as possible. The potential for MED2002 as a safe, rapid and effective treatment for erectile dysfunction is huge. We are pleased to report that discussions regarding commercialisation are progressing and we look forward to providing shareholders with a further update at the appropriate time."
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
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.
This announcement contains inside information for the purposes of article 7 of EU Regulation 596/2014