Futura Medical

MED3000: more detail on FM57 results

Lighthouse | 2 April 2020

Share this note

  • Futura Medical has presented detailed data from the pivotal FM57 Phase III Erectile Dysfunction (ED) study in a webcast. The headline results were released in December 2019 (see Update note). These showed no statistical difference between the three GTN dose arms and the DermaSys (placebo) arm, yet a strongly statistical difference vs baseline. These results suggested that this specific DermaSys formulation, now known as MED3000, was effective in its own right.
  • FM57 was a large double-blind, multi-centre trial involving 1,000 patients across c 60 centres in nine countries and undertaken by two CROs (specialist clinical research organisations). The primary efficacy endpoint was based on the erectile function domains of the IIEF questionnaire, with SEP2 and SEP3 questions from the Sexual Encounter Profile (SEP) questionnaire added. A number of secondary endpoints were also assessed.
  • The analysis shows that MED3000 achieved clear and statistically meaningful improvements over baseline across all primary and secondary endpoints, with p values of <0.001 across the Mild, Moderate, and Severe forms of ED. The results were consistent when viewed across patient groups, study centres, geographies, and CROs performing the study.
  • As we said at the time, whenever a well-structured and planned clinical trial throws up such remarkable results the first question should be whether something has gone awry in the study execution. Examples would include formulation errors, administration issues, and problems with data collection and processing. However, the analyses presented support the view that MED3000 is a potent and effective treatment for all forms of ED.
  • The quality of the data is also supported by the positive interactions with the FDA and European regulators. The documentation to support a medical device filing in Europe (Class II) and US (de novo) is being prepared and, assuming no further clinical work is required, on track for submission by end-July (Europe) and end-Q320 (US).

Trinity Delta view: The analysis of the FM57 data shows a remarkably consistent outcomes across all treatment groups and supports the view that MED3000 is an effective and safe therapy for ED. Regulatory submissions for approval of MED3000 as a medical device opens a potentially faster route to market, with probably no further clinical work required for Europe and (possibly) a small study for the US. Although difficult to compare without direct trials, the efficacy seen would suggest an activity approaching that of oral PDE5s such as tadalafil (Cialis), but with a faster onset of action and fewer side-effects. As we highlighted previously, significant unknowns remain, but the outlook is increasingly positive. We suspended our forecasts and valuation at the time of the top line FM57 results and aim to reinstate them as soon as practicable.


2 April 2020

Market Cap£23.34m
Primary exchangeAIM
Company CodeFUM
Corporate clientYes

Company description

Futura Medical is an R&D driven small pharma company, with a novel DermaSys transdermal delivery platform. The lead programme, MED3000, a topically applied gel, is being developed for erectile dysfunction (ED). A pain relief gel, TPR100, is awaiting UK approval.


Lala Gregorek
+44 (0) 20 3637 5043

Franc Gregori
+44 (0) 20 3637 5041


Trinity Delta Research Limited (“TDRL”; firm reference number: 725161), which trades as Trinity Delta, is an appointed representative of Equity Development Limited (“ED”). The contents of this report, which has been prepared by and is the sole responsibility of TDRL, have been reviewed, but not independently verified, by ED which is authorised and regulated by the FCA, and whose reference number is 185325.

ED is acting for TDRL and not for any other person and will not be responsible for providing the protections provided to clients of TDRL nor for advising any other person in connection with the contents of this report and, except to the extent required by applicable law, including the rules of the FCA, owes no duty of care to any other such person. No reliance may be placed on ED for advice or recommendations with respect to the contents of this report and, to the extent it may do so under applicable law, ED makes no representation or warranty to the persons reading this report with regards to the information contained in it.

In the preparation of this report TDRL has used publicly available sources and taken reasonable efforts to ensure that the facts stated herein are clear, fair and not misleading, but make no guarantee or warranty as to the accuracy or completeness of the information or opinions contained herein, nor to provide updates should fresh information become available or opinions change.

Any person who is not a relevant person under section of Section 21(2) of the Financial Services & Markets Act 2000 of the United Kingdom should not act or rely on this document or any of its contents. Research on its client companies produced by TDRL is normally commissioned and paid for by those companies themselves (‘issuer financed research’) and as such is not deemed to be independent, as defined by the FCA, but is ‘objective’ in that the authors are stating their own opinions. The report should be considered a marketing communication for purposes of the FCA rules. It has not been prepared in accordance with legal requirements designed to promote the independence of investment research and it is not subject to any prohibition on dealing ahead of the dissemination of investment research. TDRL does not hold any positions in any of the companies mentioned in the report, although directors, employees or consultants of TDRL may hold positions in the companies mentioned. TDRL does impose restrictions on personal dealings. TDRL might also provide services to companies mentioned or solicit business from them.

This report is being provided to relevant persons to provide background information about the subject matter of the note. This document does not constitute, nor form part of, and should not be construed as, any offer for sale or purchase of (or solicitation of, or invitation to make any offer to buy or sell) any Securities (which may rise and fall in value). Nor shall it, or any part of it, form the basis of, or be relied on in connection with, any contract or commitment whatsoever. The information that we provide is not intended to be, and should not in any manner whatsoever be, construed as personalised advice. Self-certification by investors can be completed free of charge at www.fisma.org. TDRL, its affiliates, officers, directors and employees, and ED will not be liable for any loss or damage arising from any use of this document, to the maximum extent that the law permits.

Copyright 2020 Trinity Delta Research Limited. All rights reserved.