Futura Medical plc has announced 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 randomized, 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 commercialization 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."