A safe and innovative topical treatment for erectile dysfunction

MED2002 is a topical gel applied directly to the penis for the treatment of male erectile dysfunction ("ED"). MED2002's active compound is Glyceryl Trinitrate ("GTN") which is delivered using our patented transdermal delivery system, DermaSys®. GTN is a potent vasodilator which has been used for the treatment of angina for over 100 years. It is a safe and effective drug with a known side-effects profile.

MED2002 is applied to the glans area of the penis by the user or his sexual partner. DermaSys®, our skin delivery technology, enables the active dose to be delivered effectively and rapidly through the skin. This targeted local application translates into a fast onset of efficacy with limited side effects. This is a less invasive method of application compared with other local treatments and is consistent with sexual foreplay.

How MED2002 works

The GTN in MED2002 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 - MED2002 is rapidly absorbed with rapid clearance
compared with leading PDE5i's

MED2002

Data derived from multiple studies - For illustrative purposes only

Successful clinical efficacy trial completed

A clinical efficacy study was completed in September 2016. The study met its primary endpoint and MED2002 showed efficacy, safety and speed of onset.

The study comprised a total of 232 randomised males and it measured, as its primary endpoint, improvement in the erectile function ("EF") domain score of the International Index of Erectile Function ("IIEF"). The study, which used a single dosage of 0.2% w/w of glyceryl trinitrate in a gel, was of a placebo-controlled, double blind, home use, crossover design.

The study which included mild, moderate and severe ED patients, achieved its primary endpoint in demonstrating a statistically significant improvement in erectile function (p-value = < 0.0132) in the EF domain score, averaged across the entire patient set, when using MED2002 compared with placebo.

The speed of onset of action of MED2002 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 MED2002 to be the world's fastest-acting treatment for ED.

The side effects profile was very favourable with no serious adverse events or serious adverse reactions recorded and no drop-outs from the study owing to side-effects.

The study results give us great confidence in the future development of the product. Professor David Ralph (former President of the European Society for Sexual Medicine) stated "The positive data from this study provides an exciting new innovation with the potential to be a first line therapy in erectile dysfunction. MED2002 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product. MED2002, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients."

Full results were published in February 2018 in the leading independent and peer-reviewed publication The Journal of Sexual Medicine

Efficiacy Trial Results Published

Market potential

We have conducted further external market research in 2017 to fully understand the potential opportunity that MED2002 represents as both a prescription and non-prescription treatment for erectile dysfunction in order to optimise the commercial opportunity. This market research highlighted the potential benefits of MED2002 when compared with PDE5 inhibitors.

The research, carried out by leading healthcare strategy firm Cello Health Consulting ("Cello") showed that MED2002 has the potential to be a first line treatment option for ED with 64 per cent of physicians in the US considering that MED2002 is an improvement over current ED treatments, which are dominated by PDE5 inhibitors. The research also revealed that at least 10 per cent of ED patients were contra-indicated to PDE5 inhibitors (such as Viagra® or Cialis®) because of their existing nitrate medication.*

The results highlighted that MED2002 could capture between a quarter and a third of the estimated ED patient pools in the US, including newly diagnosed and existing patients. The rapid speed of onset and the spontaneity associated with the use of the product were given by doctors as key reasons for expected patient use of the product. Our external market assessment forecasts that MED2002 as a first line therapy could achieve peak annual sales in excess of US$550 million.

US ED patient populations - Opportunity in each segment

MED2002

In addition, MED2002 has the potential to switch to over the counter. The market research firm Ipsos used its validated healthcare forecasting model to forecast peak OTC annual sales for MED2002 in key countries worldwide of more than US$650 million. Importantly, Ipsos forecasts that 73% of these potential OTC sales would be incremental to the prescription category. The key findings of the market research showed that the respondents believed that the product, once approved, would be highly differentiated from existing products. MED2002's rapid onset of action and favourable safety profile were the key features that attracted respondents to the product.

MED2002 proposition

Oral PDE5 inhibitors are the cornerstone of modern erectile dysfunction therapy, but do not meet the needs of many men and their partners. Up to half of patients discontinue treatment within one year, citing concerns which include barriers to spontaneity and intimacy, insufficient efficacy, and side effects. Erectile dysfunction affects the patient’s emotions and relationships, and an ideal ED treatment should address more than the ability to have and maintain an erection. Our research shows that around a quarter of patients are not satisfied with their ED treatment. Delayed speed of onset associated with PDE5is use is a major barrier to spontaneity and intimacy.

Because of its efficacy, rapidity and usability as a topical treatment, MED2002 has the potential to offer a new first line treatment option for couples looking for a more intimate and spontaneous solution to erectile dysfunction. MED2002 also represents a potential new treatment option for patients taking nitrates and therefore contra-indicated to oral PDE5s, for those who find PDE5s side effects unacceptable and for those who have discontinued treatment.

The research recently conducted showed that the MED2002 proposition was highly relevant with 72% of doctors considering that helping to restore spontaneity and intimacy in the relationship would be very appealing to their patients and would be a key driver of patient initiation or switch to MED2002.

"Erectile dysfunction often becomes a barrier to spontaneity and intimacy in a relationship, which harms both the man and his partner over time. MED2002 can be applied as part of foreplay, and with its fast onset of action can help to break down the barriers that have proved so difficult to overcome with existing treatments."
- Ian Eardley, Consultant Urologist, Past President of the European Society of Sexual Medicine, Department of Urology, St James University Hospital, Leeds

MED2002 - an innovation in the treatment of ED

MED2002

"Once the basic functional aspects related to erectile function have been covered, additional benefits such as 'spontaneity' and 'pleasing the partner' become important and may be critical for choosing the optimum individual treatment, to improve the sexual satisfaction and the adherence to the treatment."
- Burri, Int J Impot Res, 2015

Regulatory and Clinical development strategy

In parallel to our commercial out-licensing discussions we are finalising the development and regulatory strategy for MED2002. The FDA, MEB and MHRA (the US Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency and the Medicines Evaluation Board respectively) have signaled their broad approval of the planned development programme, which includes a pharmacokinetic ("PK") study followed by two Phase III studies. The Netherlands is likely to be the reference member state for any EU regulatory filing for MED2002 following Brexit.

The safety data from the PK study, which commenced in November 2017, showed that all doses were well-tolerated. The data indicated that Futura would be able to use at least two higher doses of MED2002 than the dose used in the Phase II study. This creates the potential for increased efficacy in the Phase III studies with the objective of being able to treat patients experiencing more severe ED. Our current plan is for the first patient in the first Phase III trial to be dosed early in Q3 this year, though the timing could be influenced by the signing of a commercial out-licensing agreement.

The clinical development programme involves:

  1. Consultations with the relevant regulatory authorities in both USA and EU to confirm the requirements for marketing authorisation and clinical trial protocols
  2. Completion of the remaining Phase III clinical programme
  3. Completion of manufacturing scale up and stability in final packaging
  4. Completion of any remaining safety studies.

    Indicative Timetable
      2017 2018 2019
      Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
    EU & USA REGULATORY MEETINGS
                   
    PHARMACOKINETIC SAFETY STUDY*      
               
    PHASE III EFFICACY STUDIES*        
     
         
    MANUFACTURING SCALE UP & STABILITY
     
     
    EU & USA REGULATORY SUBMISSIONS                  
     
     

    * Part of Phase III programme

Commercialisation

We have appointed advisers to assist in the out-licensing process of MED2002 and are encouraged by the high level of commercial interest from potential licensing partners. Commercial out-licensing discussions are at an advanced stage.

 

*Consistent with their known effects on the Nitric oxide/cyclic guanosine monophosphate (cGMP) pathway PDE5 inhibitors have been shown to potentiate the hypotensive effects of nitrates when co-administered. This combination effect is not expected to occur with MED2002 based on clinical data to date and the regulatory agencies have agreed to the inclusion of a subset of ED patients taking nitrate medication to confirm the safety profile in the Phase III clinical programme.