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Futura Medical Receives US FDA Agreement for Confirmatory Clinical study, FM71 for MED3000

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March 22, 2021

Futura Medical plc, today announces that it has received official minutes from the US Food and Drug Administration (FDA) for MED3000, the Company’s breakthrough fast acting clinically proven treatment for erectile dysfunction (“ED”), following its 4th Pre-Submission Meeting on 1st February 2021.

The minutes signify agreement between the FDA and Futura on the detailed clinical study design (protocol) for the small confirmatory clinical study, FM71, to be conducted prior to formal regulatory submission as a DeNovo Medical Device. Detailed planning for the commencement of FM71 has now begun with the first patient dosing expected H2 2021.

FM71 is designed to provide supplementary efficacy data to the previously reported FM57 study with a “least burdensome” approach and modest cost. Whilst the overall design is similar to that of the previous large phase 3 FM57 study that recruited approximately 1000 patients, no placebo (sham) cohort is required, hence the study is relatively smaller in size with approximately 100 patients.

FM71 will be a 6 month (24 weeks) duration study versus FM57 which was conducted over 3 months (12 weeks) to reassure the FDA that the efficacy does not diminish over a longer period of time. It is Futura’s belief that this is unlikely as in the FM57 study efficacy improved from the first to the third month of patient use. Two co-primary endpoints will measure the significant clinically meaningful effect as calculated using the Rosen and Araujo statistical method, a standard assessment technique for measuring Patient-Reported Outcomes, which was also used in study FM57 in which MED3000 exceeded the minimal clinically important difference as defined by Rosen et al. Both will use the International Index of Erectile Function (IIEF-EF domain); an internationally recognized and fully validated measure used in gold-standard ED clinical trials. The first co-primary endpoint measures IIEF-EF change from the baseline which was highly significantly improved at 12 weeks in FM57, and the second endpoint requires a minimum change in improvement from baseline of 4 IIEF-EF units (where a 5.1 change was achieved in FM57). Secondary endpoints include an agreed measure of the speed of onset, a key differentiating claim, where FM57 showed that 60% of subjects noticed an erection within 10 minutes.

The Company has agreed with the FDA to include tadalafil (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.

FM71 is designed as a phase 3, multicentre, comparative, randomized, open-label, home use, parallel-group study.  The recruited patients will include those suffering from mild, moderate, or severe ED, using either MED3000 or tadalafil 5mg (50 subjects per group) and will also include 20 African American patients (from a US medical center) and 80 patients recruited from Eastern Europe where sites include some of the same centers used in the FM57 study. The Company is also pleased to confirm that the Co-ordinating (Principal) Investigator will be world-renowned Professor Arthur Burnett, MD, MBA, FACS, Distinguished Professor of Urology, Johns Hopkins School of Medicine, Brady Urological Institute. Professor Burnett is also a past President of the Sexual Medicine Society.

Professor Burnett commented: “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. I am very pleased to support Futura Medical in the further clinical investigation of this novel topical treatment.”

James Barder, Chief Executive of Futura Medical commented: “We are pleased to have reached an agreement with the FDA on the clinical trial protocol for FM71 which follows closely the positive recommendation for approval from the Notified Body on the European submission for MED3000, and the recently announced Joint Collaboration agreement for the China and 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 commercialize MED3000.”

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