Patient recruitment completed for MED2005 Phase 3 study
19 June 2019
First European Phase 3 study "FM57" on track to deliver headline data by the end of 2019
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology currently focused on sexual health and pain, is pleased to announce the completion of patient recruitment for the first European Phase 3 study, "FM57", of MED2005. Futura remains on track to deliver headline data by the end of 2019.
FM57 has completed recruitment of over 1,000 patients in the study for the treatment of mild, moderate and severe erectile dysfunction ("ED"). The study includes approximately 60 centres across Central and Eastern Europe and will compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2005 against that of placebo with an initial three-month study period for each patient. FM57’s protocol incorporates feedback received from world leading key opinion leaders ("KOLs") in ED, the US and EU regulatory agencies, as well as potential commercial partners, to increase the chances of regulatory approval as well as optimising the commercial value.
James Barder, Chief Executive Officer, Futura Medical said: "We are extremely pleased to complete recruitment of over 1,000 patients for the first European Phase 3 study, "FM57", of MED2005, within our expected timelines and budget and I would like to thank all parties involved in reaching this important milestone. The Company’s focus is now on the Phase 3 data read-out at the end of the year, which we hope will significantly clinically de-risk MED2005, and help provide commercial partners with greater certainty around the potential opportunity it presents."
The potential market for this product is large with potential peak sales in excess of US $1 billion. If MED2005 is approved, there is an estimated $560M prescription-only market potential (sources: Decision Resources and Cello), and an estimated incremental $660M+ market potential as an over-the-counter (OTC) product, in markets where switch is possible. (source: Ipsos Mori forecasts commissioned by Futura).
The Company’s main focus is to deliver Phase 3 double-blind headline data by the end of 2019, given it remains a key value inflection point for us, and we continue discussions with a number of interested commercial partners for the out-licensing of MED2005.
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Tel: +44 (0) 203 950 9144
Notes to editors:
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.
The first European Phase 3 study for MED2002, referred to as "FM57", is a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study of MED2002 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment of erectile dysfunction with an open label extension. FM57 is progressing on track, with headline data expected by the end of 2019.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com