The study, dubbed FM71, will be conducted prior to formal regulatory submission for MED3000, Futura’s erectile dysfunction gel, as a DeNovo Medical Device.
Detailed planning for the commencement of FM71 has now begun with the first patient dosing expected in the second half of 2021.
Futura said FM71 is designed to provide supplementary efficacy data to the previously reported FM57 study with a “least burdensome” approach and modest cost. While the overall design is similar to that of the previous large phase 3 FM57 study that recruited about 1,000 patients, no placebo cohort is required, hence the study is relatively smaller in size with about 100 patients.
This study will last six months whereas FM57 lasted three months. The idea is to reassure the FDA that the efficacy does not diminish over a longer period of time.
Futura is confident that reduced efficacy is unlikely as the FM57 study showed efficacy improved from the first to the third month of patient use.
The company has agreed with the FDA to include tadalafil – better known to your email spam filter as Cialis – at the lowest approved dose for on-demand use (5mg) for comparative purposes only on safety, speed of onset and efficacy; non-inferiority is not required to be shown.
The co-ordinating principal investigator on the study will be Professor Arthur Burnett, who expressed his pleasure in being able to support Futura Medical in the further clinical investigation of the company’s flagship asset.
“In my humble opinion and as an expert in the field of erectile dysfunction management, I am very supportive of MED3000 and do believe that it offers an important and valid addition to the armamentarium of treatments we can offer our patients for erectile dysfunction,” Burnett said.
James Barder, the chief executive of Futura, said the company was glad to have reached an agreement with the FDA on the clinical trial protocol, which is similar to agreements reached in Europe and China & the south-east Asia region.
“These key milestones are indicative of the rapid progress we have made in the last few months on our journey to fully commercialise MED3000,” Barder said.
Liberum Capital Markets, which has a ‘buy’ rating and a 68p target price for the shares, said the minutes from Futura’s meetings with the FDA “provide a clear pathway for Futura to start work on a small confirmatory study”.
“The US opportunity is worth at least twice that of the European opportunity where Futura received confirmation of approval (due by the end of May) last Friday. Today’s announcement removes the uncertainty around the clinical trial structure for the US and adds to the significant momentum at Futura,” the broker said.
Shares in Futura were the best performers in London on Monday, soaring 67% to 77p.
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