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 can be applied by the user or his sexual partner in a manner consistent with sexual foreplay.

 

Recent clinical studies

Study code Study type Study design Doses Completed Conclusions
FM53 Phase 2a Placebo-controlled, double blind, home use, crossover design 0.2% GTN September 2016
  • Met its primary endpoint of superior improvement in erectile function compared to placebo (IIEF-EF score)
  • MED2005 showed superior sexual experience compared to placebo (other IIEF domains)
  • MED2005 was well tolerated compared with other topically applied gels or PDE5 inhibitors.
FM58 PK Open-label, randomised, six-period, reference replicate, crossover study 0.2%, 0.4%, 0.6%, 0.8% GTN April 2018
  • Clear dose proportionality for the DermaSys® topical gel.

FM57 Phase 3 Multicentre, randomised, double blind, vehicle controlled, home use, parallel group

MED3000

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

December 2019
  • Highly statistically significant improvement across all ED patient severities in their erectile function compared to before treatment
  • Begins to work immediately in some patients, with over 60% of patients seeing onset of their erection within 10 minutes of application

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.

Application of gel

Combination of solvents including volatile solvents.

Seconds later

Volatile solvents evaporate.  Rapid cooling from the evaporation of these specific combinations of solvents, with subsequent warming stimulates nerve sensors in the highly innervated glans penis.

Minutes later

Smooth muscle relaxation, tumescence and erection. Begins to work immediately for some patients and for 60% within 10 minutes1.

 

FM57 Clinical Study Data

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. Research has shown 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

Penile erection

Key

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

Clinical data demonstrating efficacy and safety profile

MED3000 is supported by  efficacy and safety data from a range of studies including a Phase 2a study and Phase 3 study.

FM53 - Phase 2a Efficacy and safety trial

The Phase 2a clinical efficacy study met its primary endpoint. The study showed statistically significant benefit over placebo using the internationally accepted IIEF-EF trial endpoints including benefits to improve erectile function, intercourse satisfaction, orgasmic function and overall satisfaction.

Cover of the Journal of Sexual Medicine

An onset of action  within 5 minutes in 44.2% of intercourse attempts and within 10 minutes in 69.5% of attempts was reported. No treatment-related serious adverse events or serious adverse reactions recorded and there were no drop-outs from the study owing to side-effects.  The data was published in February 2018 in the peer-reviewed Journal of Sexual Medicine. The study results give us great confidence in the future development of the product.

FM58 – Pharmacokinetic (PK) trial

FM58 demonstrated an increase in GTN concentration corresponds to an increase in systemic availability. This supports the Company's strong belief that the higher dose forms of MED2005 could improve efficacy, including in the more severe cases of ED. MED2005 showed rapid rates of absorption and was first detected in blood plasma in 4-5 minutes, reaching peak levels in the bloodstream within 10-12 minutes for all doses.

The results from these studies enable Futura to file under the 505(b)2 regulatory pathway in the US, once the Phase 3 programme is successfully completed.

FM57 - European Phase 3 study 

The Phase 3 study was designed to investigate the efficacy and safety of 0.2%, 0.4% and 0.6% glyceryl trinitrate (“GTN”) doses of MED2005 in 1,000 mild, moderate and severe erectile dysfunction (“ED”) patients in Europe versus DermaSys® alone (now named MED3000). MED3000 is now the codename for a formulation of DermaSys® developed specifically for the treatment of ED.

All three primary co-primary endpoints (IIEF-EF, SEP2 and SEP3) were achieved against baseline data for MED2005 and MED3000 in addition to important, supporting secondary endpoints in terms of efficacy, speed of onset, duration of action and patient meaningful differences.

However, the control arm used in the study which was Futura’s proprietary transdermal DermaSys formulation also demonstrated statistically significant and clinically meaningful top line results meaning that FM57 did not meet primary endpoints versus placebo. Whilst this placebo does not contain the active pharmaceutical ingredient, GTN, used in MED2005, it uses the key ingredients that constitute DermaSys’ proven transdermal technology and was shown to be as effective in the treatment of ED as the active doses.

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 believe stimulates nerve endings to cause an erection.  As such, it does not require the inclusion of glyceryl trinitrate.

Futura continues to assess the primary endpoint data for FM57 as well as secondary endpoints ahead of the completion of the clinical study report due by the end of April 2020. These ongoing analyses continue to provide us with valuable insights into the data as well as providing a better understanding of the mechanism of action.

The results from these studies enable Futura to pursue the medical device regulatory pathway for its erectile dysfunction (ED) product and will target mid 2020 for both regulatory submissions in the US and EU.

 

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 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 President of the European Society of Sexual Medicine

FM57 Clinical trial design

Subjects pre-screening

Run-in-period

Treatment period 1
n = 1,000

MED2005 0.2%
25% of patients

MED2005 0.4%
25% of patients

MED2005 0.6%
25% of patients

PLACEBO
25% of patients

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

The study is being conducted in nine countries across approximately 60 sites.
(Bulgaria, Latvia, Russia, Ukraine, Slovakia, Hungary, Czech Republic, Poland, Georgia)

Clear path to regulatory approval

Futura has commenced formal proceedings for MED3000 as a clinically proven treatment for ED to be approved as a medical device and will target mid 2020 for both regulatory the submissions in the US and EU.

Futura will submit its technical file for review by an EU Notified Body (Notified Bodies are the regulatory authorities that oversees the approval of medical devices within the EU for all EU countries including the UK), including the full clinical study report for FM57 and the Company’s Quality Management System in mid 2020.

Futura is due to meet the US FDA in Q1 2020. This meeting is expected to provide the FDA’s opinion on the requirements for the regulatory filing within the USA for MED3000.

 

Indicative timetable

2018

2019

2020

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

Regulatory submissions*

Pharmacokinetic safety study (FM58)

Phase 3 efficacy study (FM57)

Open label extension study (FM57)

  • If data meets qualifying criteria for EU single study pathway then EU submission Q2 2020 otherwise Q4 2020 at same time as FDA submission.
  1. Ralph DJ Topical GTN in the treatment of erectile dysfunction. J Sex Med 2018
  2. Futura Medical FM58 PK Study; Data on file.