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 unique formulation of DermaSys® using volatile solvent components specifically tailored for the treatment of ED.

MED3000 is a treatment applied directly to the  head (glans) of the penis and massaged for 15 seconds. Patients or their partners can apply the gel directly to the man’s penis as part of foreplay. It is fast-acting (60% of patients had onset of their erection within 5-10 minutes) and easy to use helping to restore spontaneity and intimacy in the relationship whilst offering an excellent safety profile.

 

Phase 3 Data - FM57 Clinical Study

Study code Study type Study design Doses Completed Conclusions
FM57 Phase 3 Multicentre, randomised, double blind, vehicle controlled, home use, parallel group

MED3000

MED2005 (0.2%, 0.4%, 0.6%, GTN)

December 2019
  • All treatment arms consistently met all primary endpoints against a pre-treatment baseline and across all ED severities as well as in a pooled ED patient population.
  • MED3000 showed efficacy, safety, speed of onset and duration of action.

MED3000 Mode of Action

MED3000 works through an evaporative and unique mode of action.  MED3000’s combination of volatile solvent components creates an evaporative and novel action that stimulates nerve sensors in the highly innervated glans penis 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. Further company analysis and research has indicated that the cooling from the evaporation of these specific combinations of solvents, with subsequent warming, following topical application of the MED3000 gel, stimulates the required physical response in order to achieve an erection.

 

Natural NO production

NANC
neurons

Endothelial cells

MED3000
Novel evaporative action stimulates nerve sensors in the highly innervated glans penis through temperature, touch and pressure

NO

GMP

GTP

PDE5i: PDE5 inhibition

Oral treatment with systemic absorption. Primarily selective for PDE5

cGMP-specific phos-phodiesterase type 5

Soluble guanylyl cyclase

cGMP

Smooth muscle relaxation

Tumescence and penile erection

Key

  • Nitric Oxide
  • Guanosine Monophosphate
  • Cyclic Guanosine Monophosphate
  • Guanosine Triphosphate
  • Nonadrenergic, Noncholinergic

Clinical Data

MED3000 is supported by efficacy and safety data from a range of studies including the recently completed Phase 3 study.

FM57 Clinical Trial Design

The 1,000 patient study included approximately 60 centres across nine Central and Eastern European countries. FM57 was a dose ranging, randomised, double-blind, placebo-controlled, home use, parallel group clinical trial. Patients 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 topically applied Glyceryl Trinitrate (GTN) (MED2005 0.2%, 0.4%, 0.6% GTN) against that of the placebo using IIEF-EF and SEP 2 and 3 as co-primary clinical endpoints in mild, moderate and severe ED patients. An ED-specific DermaSys® formulation (now known as MED3000) was used as a control arm (placebo) following regulatory requirements to have a placebo as near as possible to the active product.

Run-in period

Subjects pre-screening

4 week run-in-period to establish degree of patient's erectile dysfunction ("Baseline")

Treatment period

MED2005
0.2%
N=250

MED2005
0.4%
N=250

MED2005
0.6%
N=250

MED3000

N=250

Open Label
period*

MED2005 0.6%
N = 300 patients
6 months use*

MED2005 0.6%
N = 100 patients
12 months use*

Follow-up
period

Follow-up visit

* Following the FM57 results the open label phase was discontinued prematurely and is no longer active

FM57 Clinical Results

The results from the Phase 3 clinical study were unexpected.  MED3000 achieved positive results, with a striking consistency in being significantly statistically superior to baseline for all three co-primary endpoints (using validated and globally accepted measurement tools), as well as being statistically significant in each separate cohort of severity (mild, moderate and severe).  At one, two and three months treatment time points, highly statistically superior improvement over baseline was achieved.

Key secondary endpoints were also all statistically met compared to the pre-treatment baseline. Data analysed was positive on measures of clinically meaningful benefit which physicians, patients and regulators view as increasingly important. All formulations had a significant clinically meaningful effect in 60% of patients as calculated using the Rosen and Araujo 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 60% of patients seeing onset of their erection within 5-10 minutes of application, substantially faster than on demand oral tablets with significant benefits for spontaneous rather than pre-planned sexual intercourse.

FM57 demonstrated that MED3000 is 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 to cause an erection. 

All formulations tested in FM57, including MED3000, have demonstrated positive and statistically significant efficacy results against baseline data together with excellent safety profile. MED3000 will be of high interest to the Medical Community for those patients who are seeking a very rapid onset of action and a very low side-effect profile. It will likely find use in the substantial number of patients, especially those with ED of a mild to moderate nature and those patients who are contraindicated for use with existing products.

Dr Yacov Reisman

Consultant Urologist and Past President of the European Society of Sexual Medicine

Research and Development

Europe

In February 2020 Futura commenced formal proceedings for the approval of MED3000 as a Class IIB medical device in Europe.  In early July the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body3. In parallel since February 2020, the Company had been progressing the development of its Quality Management System (QMS) and in early August received a positive audit opinion from the Company’s designated Notified Body. These milestones pave the way for the Notified Body to complete its review of MED3000 under the new European Medical Device Regulations (MDR). Futura continues to target a 2021 European approval date.

USA

Initial presentation of existing clinical evidence from the MED3000 FM57 phase 3 study was made at a US Food and Drug Administration (“FDA”) pre-submission meeting in late February 2020.

Following receipt of the formal meeting minutes from the first pre-submission meeting in early April, the FDA agreed to a De Novo medical device application for MED3000 and invited Futura to pursue another pre-submission meeting once the company was in receipt of the final clinical study report for FM57.

In mid-July the company announced that a second pre-submission meeting with the FDA had taken place. As a result of this meeting the Board believes a pathway to a marketing approval for MED3000 in the USA has been established, and importantly, without the need for a doctor's prescription.

During the meeting the FDA indicated a requirement for certain supplementary clinical efficacy data beyond the FM57 phase 3 study completed in 2019.  This additional data will likely require a further small clinical study where patients with ED may receive MED3000 for a six-month treatment period. Futura is working proactively with the FDA to confirm design of the new clinical trial. A third pre-submission meeting with the FDA is scheduled before the end of October and ahead of the commencement of any additional study to gain FDA’s clearance before proceeding with the study.

The company has been advised by its regulatory consultants that the FDA’s preference is to adopt an interactive approach to data requirements with its clients wherever possible ahead of regulatory submissions.

Indicative timetable

2018

2019

2020

Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4

Regulatory submissions*

Phase 3 efficacy study (FM57)

Open label extension study (FM57)**

* Subject to the outcome from the follow up meeting with FDA regarding clinical data sufficiency

** Following the FM57 results the open label phase was discontinued prematurely and is no longer active

  1. Ralph DJ Topical GTN in the treatment of erectile dysfunction. J Sex Med 2018
  2. Futura Medical FM58 PK Study; Data on file.
  3. Notified Bodies are the regulatory authorities that oversee the approval of medical devices within the EU for all EU countries including the UK.