Futura Medical Regulatory News (FUM)

15 September 2021

Futura Medical Announces First Patient visit in MED3000 Confirmatory Study required for US approval

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 and currently focused on sexual health and pain, today announces that the first patient visit has occurred in the confirmatory clinical study, FM71, for MED3000 that will be supporting the US regulatory submission for the product.

MED3000 is a breakthrough, fast acting topical gel formulation for the treatment of erectile dysfunction ("ED") and is CE marked in Europe and the UK as a clinically proven topical treatment for adult men with erectile dysfunction.

The start of FM71 is in line with planning and both the FM71 and non-clinical Human Factors studies are now progressing in parallel targeting patient completion by the end of Q2 2022 in order for submission of MED3000 for US regulatory approval as a DeNovo medical device for ED treatment, with OTC classification by end Q3 2022. US marketing authorisation therefore remains on track for approval of MED3000 in Q1 2023.

James Barder, Chief Executive of Futura Medical commented: "We are pleased to announce the first patient visit in our FM71 study with MED3000 with timing as previously indicated. This is an important milestone for Futura, as the USA remains the largest market opportunity globally for ED treatments and we are making steady progress towards completing regulatory submission for MED3000 in the region. We are excited by the prospect of bringing a truly differentiated treatment option to US ED sufferers without the need for a doctor's prescription."

FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel and oral tadalafil (5 mg) tablets for the treatment of erectile dysfunction (ED) over a 24-week period. This clinical investigation is intended to assess the efficacy and safety of MED3000 gel in 100 male patients clinically diagnosed with a mix of mild, moderate and severe ED. The enrollment target will include 20 African American patients (from the US) and 80 patients from Eastern Europe.

-ENDS-

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: investor.relations@futuramedical.com 

Tel: +44 (0) 1483 685 670

www.futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Richard Lindley/ 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: futuramedical@optimumcomms.com

Tel: +44 (0) 203 922 0900

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® technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration and patient convenience. The products 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. 

MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction (ED) through a unique evaporative mode of action. Futura has conducted a Phase 3 study using MED3000 in ED, referred to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, consistently meeting all co-primary endpoints of IIEF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED. MED3000 also begins to work immediately in some patients, with 60% of patients seeing onset of their erection within 10 minutes of application. MED3000 is CE marked in Europe and the UK as a clinically proven topical treatment for adult men with erectile dysfunction.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com