logo-loader
RNS
viewFutura Medical PLC

Final Dosing of Last Patient in MED2005 Ph3 study

/**/ h1{margin-right:0cm;margin-left:0cm;font-size:24.0pt;font-family:"Times New Roman","serif";font-weight:bold;}p{margin:0cm;margin-bottom:.0001pt;font-size:11.0pt;font-family:"Calibri","sans-serif";}ol{margin-bottom:0cm;}ul{margin-bottom:0cm;}link{ color: #0563C1 }visited{ color: #954F72 } .bf{size:595.3pt 841.9pt;margin:92.15pt 72.0pt 28.4pt 72.0pt;}div.bf{}p.bw{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";font-weight: bold; line-height: 115%; text-align: justify}span.bu{font-size:14.0pt;line-height:115%}p.bx{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";font-div: italic; line-height: normal; margin-bottom: 0cm; text-align: justify}span.bs{font-size:12.0pt}p.by{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";font-weight: bold; line-height: normal; margin-bottom: 0cm; text-align: justify}span.bq{font-size:14.0pt}p.bz{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";margin-bottom:0cm;margin-bottom:.0001pt;text-align: justify;line-height:115%}p.ca{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";font-weight: bold; line-height: 115%; margin-bottom: 0cm; text-align: justify} p.cb{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";margin-bottom:0cm;margin-bottom:.0001pt;text-align: justify;line-height:normal}p.cc{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif"; font-weight: bold; line-height: normal; margin-bottom: 0cm; text-align: center}p.cd{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";font-weight: bold; line-height: 115%; margin-bottom: 0cm}p.ce{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";margin-bottom:0cm;margin-bottom:.0001pt;line-height: 115%}span.bi{color:windowtext;text-decoration:none}p.cf{margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;line-height:107%;font-size:11.0pt;font-family:"Calibri","sans-serif";text-align:justify;line-height:115%}span.bg{color:windowtext;text-decoration: none} /**/
RNS Number : 4430Q
Futura Medical PLC
21 October 2019
 

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 Executive
Angela Hildreth, Finance Director and COO

Email: [email protected]
Tel: +44 (0) 1483 685 670

Nominated Adviser and Sole Broker:
Liberum
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

Email: [email protected]

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

 

 


This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.
 
END
 
 
RESZMMMGKRKGLZM

Quick facts: Futura Medical PLC

Price: 11.89

Market: AIM
Market Cap: £24.33 m
Follow

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Futura Medical kicks off work on Phase III trial for erectile dysfunction gel

James Barder, chief executive of Futura Medical PLC (LON:FUM), tells Proactive they've begun preparatory work on the first Phase III efficacy trial for MED2002 - their topical gel for erectile dysfunction (ED). The study will recruit approximately 1,000 patients with mild, moderate and...

on 27/4/18