MED3000 CLINICAL PROGRAMME

MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").

MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").

MED3000 has been granted marketing authorisation by the FDA in the US, CE marked in Europe, UKCA marked in the UK and is gaining regulatory approval in a growing number of countries across the world. Mexico, Saudi Arabia and Australia are the latest countries to approve MED3000 as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.

Launches have commenced  in a number of countries in Europe  (including the UK) and in the United Arab Emirates by our commercial partners under the brand name Eroxon^®. Futura was granted marketing authorisation by the FDA  in June 2023 as a De Novo Medical Device with OTC classification. In July 2023 Futura entered into a ground-breaking licensing agreement with Haleon, a world leading consumer healthcare company for exclusive rights to commercialise MED3000 in the USA.

MED3000 is a unique formulation using  volatile solvent components specifically tailored for the treatment of ED.

Europe

MED3000 is authorised as a Class 2B device in the EU/EEA under the European Medical Device Regulation (MDR), allowing MED3000 to be marketed directly to consumers without the need of a doctor’s prescription across the European Union. MED3000 is the first clinically proven, pan-European topical ED treatment available without a doctor's prescription.

In April 2022, Futura was granted  UKCA certification for MED3000, supplementing the EU MDR authorisation. The UKCA mark willreplace the CE mark for medical devices in Great Britain from 1 July 2030.

USA

In June 2023, MED3000 was granted marketing authorisation by the FDA in the USA following a regulatory submission to the FDA for authorisation  as a De Novo Medical Device in October 2022, with the potential to be the first major ED treatment available OTC in the USA.

Rest of world

Our commercial partners have filed regulatory submissions in various countries with six regulatory approvals in the Middle East  (including Saudi Arabia and the United Arab Emirates), as well as Mexico and Australia, with more to follow.

MED3000 works through a unique evaporative mode of action.  MED3000’s combination of volatile components creates a novel action that stimulates nerve sensors in the highly innervated glans penis by a cooling and recovery warming effect, rapidly leading to smooth muscle relaxation, tumescence and erection as shown on the diagram below.

The glans penis is very highly innervated and there are sensors which are reactive to a range of physical sensations, including touch, pressure and temperature. Futura conducted further research and analysis in 2020 which demonstrated the mode of action for MED3000 as shown in the graph.

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.

FM71 was a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to a well-known US prescription oral medication for the treatment of ED in 96 subjects over a 24-week period. The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier which led to the FDA approval of MED3000.

FM71 investigated the efficacy and safety of MED3000 gel in male subjects clinically diagnosed with mild, moderate or severe ED against baseline (pre-treatment). Subjects were recruited from the United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.

Subjects enrolled into the FM71 study 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 ‘baseline’, after which MED3000 was used as per trial protocol for 24 weeks.

A well-known US prescription oral medication was included in a comparator arm for informational purposes only, to assess relative safety, speed of onset and overall efficacy. This enabled the FDA to determine the relative benefit/risk ratio of MED3000 versus a commercially available prescription comparator product.

FM71 results were highly positive, meeting all primary and secondary endpoints, were in-line  with data generated in the previous Phase 3 clinical study (“FM57”) and are broadly comparable with results from a recent “real world”, home user study conducted by our commercial partner, enabling FDA submission of MED3000 as De Novo Medical Device in October 2022 with FDA granting marketing authorisation in June 2023.

Data demonstrates that MED3000 presents an effective clinically proven treatment for erectile dysfunction with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for over the counter classification.

It will provide an alternative to existing ED treatments, that require a doctor’s prescription, and for those ED sufferers seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those ED sufferers who are currently precluded from using current prescription treatments such as men taking nitrate medication.