Highly positive FM71 Phase 3 study results with all primary and secondary endpoints achieved, MED3000 remains on track to submit for FDA marketing authorization

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announces positive results from the confirmatory Phase 3 clinical study, “FM71” for MED3000, an investigational therapy for the treatment of erectile dysfunction (“ED”).

Key highlights about the FM71 study:

• Co-primary endpoints that were agreed to with the U.S. Food and Drug Administration (FDA) were met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks.
• Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study.
• Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate, and severe ED sufferers.
• Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favorable side-effect profile.

• Futura is on track to file its dossier with the FDA by the end of September, targeting marketing authorization by the FDA of MED3000 in Q1 2023 as the first major ED treatment available over-the-counter (OTC) classification I.

James Barder, Chief Executive Officer, Futura Medical said: “We are excited at the prospect of bringing a truly differentiated treatment option for men in the USA with ED without the need for a doctor’s prescription. The data generated is another important milestone for Futura, as the USA remains the largest market opportunity globally for ED treatments. Following multiple productive and positive pre-submission meetings held with the FDA to discuss the pathway to OTC status, as well as the additional clinical and non-clinical requirements, we hope to achieve a fast and successful review for MED3000 and continue to target US OTC FDA marketing authorization for MED3000 in Q1 2023. In the USA all clinically proven oral ED therapies are prescription-only and therefore MED3000 has the potential to be a significant innovation with its key differentiator of a rapid speed of onset and by creating a major new OTC category for ED treatment.”

Ken James, Executive Director, and Head of R&D added: “Data shows that MED3000 is effective across all ED patient severities and achieves clinically important efficacy at each time point up to and including 24 weeks. Notably, MED3000 helps men achieve first signs of an erection within 10 minutes according to pre-determined statistical criteria agreed to with the FDA. MED3000 has also demonstrated excellent safety in comparison with prescription oral medication, and as such, has a very favorable benefit to risk profile making it ideally suited to OTC classification throughout the USA.”

Webcast

James Barder, Chief Executive Officer, and Ken James, Executive Director, and Head of R&D, will host a pre-recorded webcast to discuss the data at 10am BST, 31 August 2022 (5am ET), which can be found within the Investor Centre section of the Futura company website at www.futuramedical.com.

MED3000 is CE marked in Europe and CA marked in the UK, as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.

FM71 results are highly positive, in line with data generated in the previous Phase 3 clinical study (“FM57”) and broadly comparable with results from a recent “real world”, home-user study.

Accumulated MED3000 clinical data demonstrates that it may be a treatment option with a rapid onset of action and favorable risk versus benefit profile ideally suited for OTC classification¹. It is expected to provide an alternative to existing ED treatments, that require a doctor’s prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also may provide an important treatment option for those patients who are currently precluded from using current prescription treatments, such as those men taking nitrate medication.

FM71 Trial Design

FM71 is a multi-center, randomized, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to oral tadalafil (5mg) tablets for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed to with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which the company continues to target filing by the end of September 2022.

FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate, and 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.

Patients 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.

Efficacy – Co-Primary Endpoints

Co-primary endpoints pre-determined with the FDA were achieved for MED3000. The first showed a highly statistically significant improvement, P<0.001, against baseline at 24 weeks in erectile function (as measured by the gold standard, internationally recognized International Index of Erectile Function-Erectile Function (IIEF-EF) score) across ‘pooled’ severities of ED (mild, moderate, and severe). The 24-week time point demonstrated durability of response to treatment beyond 12 weeks (studied previously in FM57) which was specifically requested by the FDA.

The second primary endpoint, again using the IIEF-EF scale, showed that on average patients experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference (“MCID”). This standard, as defined in scientific papers by Rosen et al², is internationally accepted as a key criterion demonstrating meaningful difference in improvement of erections, and therefore is of clear benefit to patients.

Onset of Action - Secondary Endpoints

FM71 also included FDA agreed criteria for proving a rapid onset of action. Data demonstrated a highly statistically significant improvement, P<0.001, at 10 minutes where patients noticed an erection. Oral tadalafil (5mg tablets) did not meet the criteria at the same time point. Oral tablets typically take 30-60 minutes to work and therefore a claim for MED3000, such as “helps you get an erection within 10 minutes,” represents a significant advancement in therapy over existing oral tablets.

Exploratory Endpoints

A number of exploratory endpoints were studied with key highlights as follows:

• Using the well-established Self Esteem and Relationship (SEAR) questionnaire, it was determined that at week 24, 85.4% of MED3000 users felt that sex could be spontaneous (Includes: Always/Almost Always/Most times/Sometimes), reaffirming the rapid onset of action and key user benefit.
• Using the IIEF-EF scale, MED3000 was shown to exceed the MCID of 4 units at each time point; 4 weeks (4.59 units), 8 weeks (5.20), 12 weeks (5.12), 16 weeks (5.83), 20 weeks (5.57) and 24 weeks (5.73). Generally, there was an improvement in IIEF-EF score over the 24-week duration of the study and importantly there was no decline in efficacy between 12 and 24 weeks. The potential for a decline in efficacy between 12 and 24 weeks had been previously raised by FDA as a potential issue.
• An average of results over the 24 weeks, showed that MED3000 exceeded the MCID for subgroups of mild, moderate, and severe ED sufferers.

Safety and Tolerability

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 with a highly favorable overall side-effect profile. Of particular note is that 19.1% of tadalafil users experienced a headache on at least one occasion while using the product versus 4.3% of MED3000 users; headache is a known side-effect of prescription oral medications for ED. 4.3% tadalafil users also noted back pain and 4.3% “non-cardiac” chest pain (three cases of moderate, and one mild in the US population). No instances of back pain or chest pain were noted with MED3000 although 4.3% users noted nausea (2 subjects). Only one instance of mild local burning was noted in MED3000 users and no instances of local side-effects in female partners.

Summary comparison of MED3000 versus tadalafil in FM71

Both MED3000 and tadalafil exceeded the minimal clinically important differences at all time points and for all ED severities however overall tadalafil showed a greater improvement in erectile function than MED3000. MED3000 achieved the FDA agreed criteria for proving a rapid onset of action at 10 minutes where patients noticed an erection whereas tadalafil did not achieve the agreed criteria. MED3000 also showed a more favorable side effect profile compared to tadalafil.

Comparison of FM71 with previously conducted Phase 3 clinical trial, FM57

Data from FM71 study reaffirms previously published results from FM57, which showed MED3000 to be rapid-acting with first signs of erection within 10 minutes. At 4, 8 and 12-week time points highly statistically superior improvement over baseline was achieved with very similar IIEF-EF scores in both studies. Safety and tolerability data was also consistent with FM57, with no serious adverse events recorded in any patient or their female partner on MED3000 as well as a highly favourable overall side effect profile.

Next Steps

As previously announced, the FDA has agreed that an application may be made for MED3000 as a medical device for ED treatment, with a De Novo classification. Data from this confirmatory clinical study, FM71, alongside additional data from FM57, supports the US regulatory submission for MED3000 with an application for OTC designation. The dossier is on track for submission at the end of September 2022.

US marketing authorization of MED3000 by the FDA remains on course for Q1 2023.

1. OTC – available without the need of a doctor’s prescription
2. Minimal Clinically Important Differences in the Erectile Function Domain of the International Index of Erectile Function Scale Rosen et al

https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.960.9423&rep=rep1&type=pdf

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014 as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration, and patient convenience. The products are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialization strategies are designed to maximise product differentiation and value creation while minimising risk.

MED3000 is Futura’s topical gel formulation that is a breakthrough treatment for erectile dysfunction (“ED”) through a unique evaporative mode of action. Futura has previously conducted a Phase 3 study using MED3000 in ED, referred to as “FM57”. This was a 1,000 patient, dose-ranging, multi-center, randomized, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED.

MED3000 is CE marked in Europe and CA marked in the UK as a clinically proven topical treatment for adult men with erectile dysfunction under the brand Eroxon™ with a key claim of “Helps you get an erection within 10 minutes”.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com

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