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1st Patient Enrolled in European Ph3 MED2002 study
1st Patient Enrolled in European Ph3 MED2002 study.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 7768F Futura Medical PLC 31 October 2018 \n\nTHE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER ARTICLE 7 OF REGULATION (EU) NO 596/2014 OF THE MAR. UPON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN\nFutura Medical Announces First Patient Enrolled in European Phase 3 study of MED2002 for the Treatment of Erectile Dysfunction\n31 October 2018\nFutura Medical plc (AIM: FUM) (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, today announces that the first patient has enrolled in the first European Phase 3 study, (\"FM57\"), of MED2002, a topical glyceryl trinitrate (\"GTN\") gel for the treatment of erectile dysfunction (\"ED\"). The Phase 3 study remains on track, with headline data expected by the end of 2019.\n \nJames Barder, Chief Executive Officer of Futura Medical said: \"We are pleased to announce the first patient enrolment in our first European Phase 3 trial with MED2002. This is an important milestone for Futura, building on the success of both the Phase 2 and PK data.\n \n\"Futura is now in a position to build value by progressing the development of MED2002 through its planned Phase 3 studies, and we are excited to be moving closer to bringing an innovative, highly differentiated ED product to market that could help the many ED patients whose needs are not met by current treatments.\"\n \nFM57 is a dose-ranging, multi-centre, randomised, double-blind, placebo-controlled, home use, parallel group clinical trial of topically applied GTN and will recruit approximately 1,000 patients with mild, moderate or severe ED and compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2002 against that of placebo. The trial will include at least 60 centres across Central and Eastern Europe to ensure patients are recruited as quickly and efficiently as possible.\n \nThe Company's successful Phase 2 study (\"FM53\") achieved its primary clinical endpoint and demonstrated efficacy, safety and a rapid speed of onset in 0.2% GTN dose. Results of this study were published...