Last checked at 21 Oct 2019 07:00
Final Dosing of Last Patient in MED2005 Phase 3 study
First European Phase 3 study "FM57" on track to deliver headline data by the end of 2019
Patient recruitment complete for open label extension study
21 October 2019
Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, is pleased to announce that all patients have now completed dosing in the first European Phase 3 study, "FM57", of MED2005. Futura remains on track to deliver headline data by the end of 2019. In addition, patient recruitment has recently been completed for the required 12 month open-label extension study ("OLE").
Final FM57 dosing complete
FM57 is a pivotal 1,000 patient study that includes approximately 60 centres across Central and Eastern Europe. This Phase 3 study is a dose ranging, randomised, double blind, placebo controlled, home use, parallel group clinical trial and evaluates the efficacy and safety of 0.2%, 0.4% and 0.6% GTN doses of MED2005 in mild, moderate and severe erectile dysfunction ("ED") patients.
Open Label Extension study
A 12-month open-label extension study to assess long-term safety and tolerability of a drug is a standard regulatory requirement for drugs intended for long-term treatment of non-life-threatening conditions, such as ED. In line with advice received from regulatory authorities, Futura has designed an OLE in which subjects recruited from primarily high patient volume countries are invited to enter into the OLE on the 0.6% dose a few days after completing the double-blind phase and follow up visit of FM57. In OLE studies, generally 300 to 600 patients are evaluated for 6 months and at least 100 of those patients for 12 months; defined by the International Conference on Harmonisation (ICH) guideline E1. Therefore, to meet this requirement, Futura are pleased to announce that 450 subjects from the double-blind phase of FM57 have agreed to enter the OLE study. As previously reported on 11 September 2019 interest in patients electing to enter the OLE remained high having completed the double-blind phase of FM57.
James Barder, Chief Executive Officer, Futura Medical said: "We are extremely pleased to have achieved this important milestone and look forward to the Phase 3 data read out, which is on track to deliver headline efficacy and safety data in December this year, a key value inflection point for the Company.
"It is estimated that one in six men will experience some form of ED in their lives. We believe MED2005 will offer new hope to ED suffers, in an area that has seen little innovation for nearly two decades and has the potential to be a first line treatment option for ED."
ENDS
For further information please contact:
Futura Medical plc James Barder, Chief ExecutiveAngela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.comTel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:LiberumBidhi Bhoma/ Euan Brown/ Kane CollingsTel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
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 MED2005, referred to as "FM57", is a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study of MED2005 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