MED2005 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").

MED2005 can be applied by the user or his sexual partner in a manner consistent with sexual foreplay.

DermaSys®, our transdermal drug delivery technology platform, enables the active compound to be delivered effectively and rapidly through the skin. This targeted local application translates into a fast onset of action with rapid clearance. This fast onset of action (5-10 minutes) makes MED2005 potentially the fastest-acting ED treatment on the market.

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
  • MED2005 showed efficacy, safety and speed of onset
FM58 PK Open-label, randomised, six-period, reference replicate, crossover study 0.2%, 0.4%, 0.6%, 0.8% GTN April 2018
  • Excellent dose proportionality for a topical gel supporting increased likelihood that increasing the dose will increase efficacy
FM57 Phase 3 Multicentre, randomised, double blind, placebo controlled, home use, parallel group 0.2%, 0.4%, 0.6%, GTN Ongoing – Headline results expected end 2019
  • Study ongoing
  • Endpoints – Efficacy and safety of MED2005 in a larger patient sample and at higher doses using the EF-IIEF and SEP questionnaires

How MED2005 works

MED2005's active compound is Glyceryl Trinitrate ("GTN"). The GTN in MED2005 is absorbed into the penile blood system and is converted to nitric oxide, which has the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries. This allows the corpus cavernosa to engorge with blood and, following sexual stimulation, a natural erection occurs.

Application of gel with active GTN

Combination of solvents including volatile solvents

Seconds later

Volatile solvents evaporate, leaving the remaining solvent supersaturated with active GTN.
The supersaturation powerfully drives GTN through the tissue rapidly

Minutes later

Rapid absorption into corpus cavernosum, with erection in around 5-10 minutes

GTN rapidly enters the systemic circulation and is rapidly cleared

MED2005 Mechanism of Action

MED2005’s active compound, glyceryl trinitrate (GTN) promotes vasodilation through local absorption, rapidly targeting the penile vasculature, minimising systemic uptake. MED2005 targets the production of NO which leads to smooth muscle relaxation and ultimately penile erection as shown on the diagram below.

Natural NO production

NANC
neurons

Endothelial cells

MED2005 GTN
Targeted treatment to drive additional NO where it is needed

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

PK data for MED2005 compared with leading oral PDE5s

Comparative pharmacokinetics - MED2005 is rapidly absorbed with potential for prolonged action compared with leading PDE5i's.

Comparative dual axis pharmacokinetic graph comparing MED2005 (0.6%) vs Viagra (100mg) and Cialis (20mg) over 4hrs.

MED2005-chart

Data derived from multiple studies - illustrative purposes only

Compelling clinical data showing efficacy and safety profile

MED2005 is supported by compelling efficacy and safety data from a range of studies including a Phase 2a study, with the European Phase 3 study ongoing.

FM53 - Phase 2a Efficacy and safety trial

The Phase 2a clinical efficacy study met its primary endpoint and MED2005 showed efficacy in ED, safety and speed of onset. 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.

The speed of onset of action of MED2005 was rapid, with an onset of action within 5 minutes in 44% of intercourse attempts and within 10 minutes in almost 70%, offering the potential for MED2005 to be the world's fastest-acting treatment for ED. The side effects profile was very favourable with no treatment-related serious adverse events or serious adverse reactions recorded and 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 should 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 also provide reassurance that there is likely to be minimal risk in transference of GTN to the sexual partner during intercourse and are consistent with the side effects profile seen in the Phase 2 study. The results enable Futura to file under 505(b)2 route in the US once the Phase 3 programme is successfully completed.

The positive data from this study provides an exciting new innovation with the potential to be a first line therapy in erectile dysfunction."

"MED2005 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product."

"MED2005, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients.

Professor David Ralph

Consultant Urologist

St Peter's Andrology Centre & Institute of Urology, UCLH, London

Past President of the European Society of Sexual Medicine

European Phase 3 study ongoing (FM57)

The first Phase 3 trial is a dose ranging, multicentre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically applied GTN MED2005 (study registered on ClinicalTrials.gov). This study has completed recruitment of approximately 1,000 patients at European centres with mild, moderate or severe ED and compares the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2005 against that of placebo using IIEF-EF clinical endpoints. The trial is being conducted throughout Central and Eastern Europe with a three-month study period for each patient. After patients complete this first phase, they are invited to enter the open label extension study (“OLE”) to assess safety primarily, in compliance with international guidelines, at the highest dose (0.6% GTN) up to the required number of patients. We anticipate headline efficacy results of the double-blind phase on the first Phase 3 by end of December 2019.

The second Phase 3 study (FM59) will start sequentially, will be confirmatory and include a cohort of US patients. The study will be a placebo controlled, parallel group study and will likely compare the efficacy of two GTN doses of MED2005, shown to be optimal in the first Phase 3 trial, in around 700 patients.

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

The development and regulatory strategy for MED2005 has been finalised. The FDA, MEB and MHRA1 have signaled their broad approval of the planned development programme, which apart from the recently completed PK study detailed above requires two Phase 3 studies, one of which FM57 is under way as detailed above. The Netherlands is likely to be the reference member state for any EU regulatory filing for MED2005 following Brexit.

Indicative timetable

  • If data meets qualifying criteria for EU single study pathway then EU submission Q2 2020 otherwise Q4 2020 at same time as FDA submission
  • Regulatory and ethics submissions expected in H2 2019 to allow patient enrolment to commence H1 2020
  • The US Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency and the Medicines Evaluation Board respectively