MED3000 is supported by efficacy and safety data from a range of studies including the completed Phase 3 studies FM57 and a US confirmatory Phase 3 study, FM71.
FM57 Phase 3 Study
The 1,000 patient study included approximately 60 centres across nine Central and Eastern European countries. FM57 was a randomised, double-blind, placebo-controlled, home use, parallel group clinical trial. Subjects being enrolled into FM57 for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED, known as the pre-treatment ‘baseline’.
FM57, the Phase 3 study was designed to investigate the efficacy and safety of a range of topically applied gels using IIEF-EF and SEP 2 and 3 as co-primary clinical endpoints in mild, moderate and severe ED patients.
FM57 Clinical Results
In study FM57, MED3000 consistently showed statistical improvement over pre-treatment, baseline and achieved clinically important differences across all ED severities. MED3000 also showed efficacy and a rapid speed of onset with an excellent safety profile.
FM57 demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction. MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis by a cooling and recovery warming effect to cause an erection.
MED3000 results demonstrated a highly statistically significant improvement (p<0.001) in erectile function across ‘pooled’ patient severities (mild, moderate, and severe) as well as being statistically significantly superior within the separate mild, moderate and severe groups, compared to before treatment baseline, along with an excellent safety profile.
Data analysed was positive on measures of clinically meaningful benefit which physicians, ED sufferers and regulators view as increasingly important. MED3000 had a significant clinically meaningful effect in over 60% of patients as calculated using the Rosen1 and Araujo2 statistical methods, standard assessment techniques for measuring Patient Reported Outcomes recognised and accepted by leading ED experts.
MED3000 begins to work immediately in some patients, with over 60% of patients seeing onset of their erection within 10 minutes of application, substantially faster than reported for PDE5i's (oral tablets) with significant benefits for spontaneous rather than pre-planned sexual intercourse.
Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patient, or their female partners.