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.

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.

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

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

Data derived from multiple studies - illustrative purposes only

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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 2 study, with the European Phase 3 study ongoing.

Details of the key clinical studies are summarised in the table below.

Recent clinical studies for MED2005

Study code Study type Number of subjects Study design Doses Completed Conclusions

FM53

Phase 2

231 men and their female partners

Placebo-controlled, double blind, home use, crossover design

0.2%
w/w GTN

September 2016

  • Met its primary endpoint
  • MED2005 showed efficacy, safety and speed of onset

FM58

PK

Part 1 - 31 men

Part 2 - 10 men

Open-label, randomised, six-period, reference replicate, crossover study

0.2%, 0.4%, 0.6% 0.8% w/w GTN

April 2018

  • Excellent dose proportionality for a topical gel supporting increased likelihood that increasing the dose will increase efficacy

FM57

Phase 3

Targeted recruitment of 1,000 men and their female partners

Multicentre, randomised, double blind, placebo controlled, home use, parallel group

0.2%, 0.4%, 0.6% w/w GTN

Ongoing - Headline results expected end 2019

  • Study ongoing
  • Endpoints - Efficacy and safety of MED2002 in a larger patient sample and at higher doses using the EF-IIEF and SEP questionnaires.

 


1. Successful Pharmacokinetic ("PK") trial completed (FM58)

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.

Successful Pharmacokinetic ("PK") trial completed - FM58

FM58
Study design

Doses: 0.2%, 0.4%, 0.6% and 0.8% w/w GTN

Objective: PK study to assess their suitability for maximising efficacy in the treatment of ED

Completed April 2018

  • GTN demonstrated a rapid rate 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.
  • 75% of MED2005 was absorbed within 5 minutes as measured by penile swabbing, leaving a low GTN residue on the penis at 5 minutes
  • All doses of GTN were well tolerated by the subjects. Adverse events reported were generally mild and at an acceptable level, even at the highest dose.
  • Importantly, the incidence of headache, a known adverse event of GTN, did not increase significantly at the higher doses
  • Blood plasma concentrations of GTN of 0.2%, 0.4% and 0.6% fell within the plasma concentrations of the chosen US reference product, Nitrostat®, which is used to treat angina

FM58
Conclusions

  • Results are consistent with the rapid onset of action in the Phase 2 study
  • Results 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.
  • Results enable Futura to file under 505(b)2 route in the US once the Phase 3 programme is successfully completed
  • Plasma concentrations demonstrated excellent dose proportionality for a topical gel supporting increased likelihood that increasing dose will increase efficacy

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2. Successful Phase 2 clinical efficacy and safety trial completed (FM53)

A clinical Phase 2 efficacy study was completed in September 2016. The 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 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.

"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

Successful Phase 2 Efficacy and Safety trial completed - FM53

FM53
Study design

Dose: 0.2% w/w GTN
Subjects: 232 men with ED

Design: placebo-controlled, double blind, home use, crossover design

Primary endpoint: Evaluate efficacy of MED2005 using the International Index for Erectile Function (IIEF) questionnaire

Completed in 2016

  • Primary objective achieved in FM53 in demonstrating clinical efficacy in men with ED using the industry standard IIEF questionnaire
    • Statistically significant difference vs placebo overall (P = 0.0132)
  • Statistically significant in mild and mild to moderate ED groups
  • MCID* was achieved in 60.8% of MED2005 subjects and 33.1% of placebo subjects in the mild and mild to moderate groups (IIEF-EF≥ 2)
  • Good safety profile - No serious adverse effects or withdrawals giving significant scope to increase dosage in Phase 3 studies
  • Rapid speed of onset in subjects - the mode of action supports the speed of onset with 44.2% of patients < 5 minutes, 69.5% < 10 minutes
    • MED2005 doses detectable in the systemic circulation within 5 minutes (PK study FM58)

FM53
Conclusions

Published in the Journal of Sexual Medicine in February 2018

  • FM53 met its primary endpoint and MED2005 showed efficacy, safety and speed of onset.
  • 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
  • Clinical data indicate that MED2005 is well-tolerated, with a lower potential than PDE5 inhibitors for systemic side effects

* Rosen et al 2011 defined the Minimal Clinically Important Difference (MCID) in the mild ED group as a 2-unit change (based on analysis of 17 randomised double blind placebo controlled Tadalafil studies)

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European Phase 3 study ongoing (FM57)

The first Phase 3 trial, will be 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 will recruit approximately 1,000 patients at European centres with mild, moderate or severe ED and compare the efficacy of 0.2%, 0.4% and 0.6% w/w GTN doses of MED2005 against that of placebo using IIEF-EF clinical endpoints. The trial will be conducted throughout Eastern Europe with a three-month study period for each patient. Long term safety data will also be recorded in compliance with international guidelines and reported separately. The second Phase 3 study (FM59) will start sequentially, will be confirmatory and include a cohort of US patients.

Depending on the speed of regulatory approval and patient recruitment proceeding in line with reasonable expectations, we would anticipate headline efficacy results by end of December 2019.

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 already 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 2018 2019 2020
  Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
REGULATORY SUBMISSIONS*                  
 
 
PHARMACOKINETIC SAFETY STUDY
               
PHASE 3 EFFICACY STUDY (FM57)
 
   
PHASE 3 EFFICACY STUDY (FM59)**              
 
 

* If data meets qualifying criteria for EU single study pathway then EU submission Q2 2020 otherwise Q4 2020 at same time as FDA submission
** Exact timing of 'First Patient In' dependent on FM57 results and potential funding
1 The US Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency and the Medicines Evaluation Board respectively