Futura Medical plc has announced the following update on progress of its pivotal efficacy study of MED2002.
Recruitment of patients for the study is proceeding well, with 118 patients having enrolled in the study to date. Once enrolled, the clinical test period per patient is approximately three months. A total of 192 patients are expected to take part in the trial, which remains on track to deliver headline results by the end of H1 2016.
All of the patients recruited to date have been enrolled in London and, as previously advised, further recruitment sites within the EU have been identified. Ethics approvals for these sites have now been obtained and pending regulatory approval overseas recruitment is expected to commence in the New Year.
No serious adverse events have been recorded to date among the patients who have participated in the trial, which is of a randomized, placebo-controlled, double blind, home use, crossover design. Because the trial is blinded, efficacy data will not be available until the end of the trial.
The primary endpoint of the study 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 include the speed of onset.
James Barder, Futura’s Chief Executive, commented: “We are pleased by the pace of recruitment to this pivotal trial of MED2002 in erectile dysfunction. MED2002 is a novel, topical gel with potential benefits including the speed of onset of action and the use of the product as part of sexual foreplay. The current trial is focused on demonstrating efficacy and remains on track to deliver headline results by the end of the first half next year.”