Futura Medical PLC First Patient visit in MED3000 Confirmatory Study (7712L)
15 Septiembre 2021 - 12:59AM
UK Regulatory
TIDMFUM
RNS Number : 7712L
Futura Medical PLC
15 September 2021
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(R) 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(R) technology. Each DermaSys(R)
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
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