REG - Futura Medical PLC - Highly positive FM71 Phase 3 Study Results

Futura MedicalAnnouncement

31/08/2022 07:00

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RNS Number : 6658X  Futura Medical PLC  31 August 2022

 

31 August 2022

Futura Medical plc

("Futura" or the "Company")

Highly positive FM71 Phase 3 Study Results with all primary and secondary
endpoints achieved, MED3000 remains on track to obtain US FDA marketing
authorisation

 

Futura Medical plc (AIM: FUM), 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 positive results from the confirmatory Phase 3 clinical study,
"FM71" for MED3000 for the treatment of erectile dysfunction ("ED").

 * FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically
significant improvement in erectile function compared to baseline, as well as
achieving a clinically important improvement in erectile function at 24 weeks

 * Secondary endpoint met demonstrating a 10-minute onset of action, which was
demonstrably faster than the well-known prescription oral medication used in
the study

 * Exploratory endpoints demonstrated MED3000 achieved clinically important
improvements in erectile function at all time points and was clinically
effective in mild, moderate and severe ED sufferers

 * Safety and tolerability data were also highly positive, with no serious
adverse events recorded in any patients on MED3000 and overall, with a highly
favourable side-effect profile

 * MED3000 presents an effective clinically proven treatment for erectile
dysfunction ("ED") with a rapid speed of onset and a favourable benefit versus
risk profile ideally suited for Over the Counter ("OTC") classification(1)

 * Futura on track to file dossier with the US FDA by the end of September,
targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the
first major ED treatment available OTC throughout the USA

 

MED3000 is a breakthrough, fast acting topical gel formulation for the
treatment of ED and is CE marked in Europe and CA marked in the UK, as a
clinically proven topical treatment for adult men with ED that helps men get
an erection within 10 minutes.

 

FM71 results are highly positive, in line with data generated in the previous
Phase 3 clinical study ("FM57") and broadly comparable with results from a
recent "real world", home use study.

 

Accumulated MED3000 clinical data demonstrates that it presents an effective
treatment option with a rapid onset of action and a favourable risk versus
benefit profile ideally suited for OTC classification1. It is expected to
provide an alternative to existing ED treatments, that require a doctor's
prescription, for those patients seeking fewer systemic side-effects, and a
spontaneous intercourse experience. It also provides an important treatment
option for those patients who are currently precluded from using current
prescription treatments such as those men taking nitrate medication.

 

FM71 Trial Design

FM71 is a multi-centre, randomised, open-label, home use, parallel group,
clinical investigation of topically applied MED3000 gel compared to oral
tadalafil (5mg) tablets for the treatment of ED over a 24-week period. The
trial design and clinical endpoints were agreed with the FDA as a confirmatory
clinical trial for the US regulatory dossier for MED3000 which we continue to
target filing by the end of September 2022.

 

FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients
clinically diagnosed with a mix of mild, moderate and severe ED against
baseline (pre-treatment). Subjects were recruited from United States (African
Americans), Poland, Georgia and Bulgaria and included men who had organic and
psychological ED or a combination of both.

 

Patients enrolled into the FM71 study for the initial four weeks had to
attempt intercourse on at least four occasions in order to establish the
severity of their ED known as the 'baseline', after which MED3000 was used as
per trial protocol for 24 weeks.

 

Efficacy - Co-Primary Endpoints

Co-primary endpoints pre-determined with the FDA were achieved for MED3000.
The first showed a highly statistically significant improvement, P<0.001,
against baseline at 24 weeks in erectile function (as measured by the gold
standard, internationally recognised IIEF-EF score) across 'pooled' severities
of ED (mild, moderate and severe). The 24-week time point demonstrated
durability of response to treatment beyond 12 weeks (studied previously in
FM57) which was specifically requested by the FDA.

 

The second primary endpoint, again using the IIEF-EF scale, showed that on
average patients experienced a 5.73 unit change in IIEF-EF score versus
baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and
defined as the Minimal Clinical Important Difference ("MCID"). This standard,
as defined in scientific papers by Rosen et al(2), is internationally accepted
as a key criterion demonstrating meaningful difference in improvement of
erections, and therefore is of clear benefit to patients.

 

Onset of Action - Secondary Endpoints

FM71 also included FDA agreed criteria for proving a rapid onset of action.
Data demonstrated a highly statistically significant improvement, P<0.001,
at 10 minutes where patients noticed an erection. Oral tadalafil (5mg tablets)
did not meet the criteria at the same time point.  Oral tablets typically
take 30-60 minutes to work and therefore a claim for MED3000 such as "helps
you get an erection within 10 minutes" represents a significant advancement in
therapy over existing oral tablets.

 

Exploratory Endpoints

A number of exploratory endpoints were studied with key highlights as follows:

 * Using the well-established Self Esteem and Relationship (SEAR) questionnaire,
it was determined that at week 24, 85.4% of MED3000 users felt that sex could
be spontaneous (includes:  Always/Almost Always/Most times/Sometimes),
reaffirming the rapid onset of action and key user benefit

 * Using the IIEF-EF scale, MED3000 was shown to exceed the MCID of 4 units at
each time point; 4 weeks (4.59 units), 8 weeks (5.20), 12 weeks (5.12), 16
weeks (5.83), 20 weeks (5.57) and 24 weeks (5.73). Generally, there was an
improvement in IIEF-EF score over the 24-week duration of the study and
importantly there was no decline in efficacy between 12 and 24 weeks.  The
potential for a decline in efficacy between 12 and 24 weeks had been
previously raised by the FDA as a potential issue

 * An average of results over the 24 weeks, showed that MED3000 exceeded the MCID
for subgroups of mild, moderate and severe ED sufferers

 

Safety and Tolerability

Safety and tolerability data were also highly positive, with no serious
adverse events recorded in any patients on MED3000 with a highly favourable
overall side-effect profile. Of particular note is that 19.1% of tadalafil
users experienced a headache on at least one occasion whilst using the product
versus 4.3% of MED3000 users; headache is a known side-effect of prescription
oral medications for ED. 4.3% tadalafil users also noted back pain and 4.3%
"non-cardiac" chest pain (three cases of moderate and one mild in the US
population). No instances of back pain or chest pain were noted with MED3000
although 4.3% users noted nausea (two subjects). Only one instance of mild
local burning was noted in MED3000 users and no instances of local
side-effects in female partners.

 

Summary comparison of MED3000 versus tadalafil in FM71

Both MED3000 and tadalafil exceeded the minimal clinically important
differences at all time points and for all ED severities however overall
tadalafil showed a greater improvement in erectile function than MED3000.
MED3000 achieved the FDA agreed criteria for proving a rapid onset of action
at 10 minutes where patients noticed an erection whereas tadalafil did not
achieve the agreed criteria. MED3000 also showed a more favourable side effect
profile compared to tadalafil.

 

Comparison of FM71 with previously conducted Phase 3 clinical trial, FM57

Data from the FM71 study reaffirms previously published results from FM57,
which showed MED3000 to be rapid-acting with first signs of erection within 10
minutes. At 4, 8 and 12-week time points highly statistically superior
improvement over baseline was achieved with very similar IIEF-EF scores in
both studies. Safety and tolerability data was also consistent with FM57, with
no serious adverse events recorded in any patient or their female partner on
MED3000 as well as a highly favourable overall side effect profile.

 

Next Steps

As previously announced, the FDA has agreed that an application may be made
for MED3000 as a medical device for ED treatment, with a De Novo
classification. Data from this confirmatory clinical study, FM71, alongside
additional data from FM57, supports the US regulatory submission for MED3000
with an application for OTC designation. The dossier is on track for
submission at the end of September 2022.

 

US marketing authorisation of MED3000 by the FDA remains on course for Q1
2023.

 

James Barder, Chief Executive Officer, Futura Medical said: "We are excited at
the prospect of bringing a truly differentiated treatment option for men in
the USA with ED without the need for a doctor's prescription. The data
generated is another important milestone for Futura, as the USA remains the
largest market opportunity globally for ED treatments. Following multiple
productive and positive pre-submission meetings held with the FDA to discuss
the pathway to OTC status, as well as the additional clinical and non-clinical
requirements, we hope to achieve a fast and successful regulatory clearance
for MED3000 and continue to target US OTC FDA marketing authorisation for
MED3000 in Q1 2023. In the USA all clinically proven oral ED therapies are
prescription-only and therefore MED3000 has the potential to be a significant
innovation with its key differentiator of a rapid speed of onset and by
creating a major new OTC category for ED treatment."

 

Ken James, Executive Director and Head of R&D added: "Data shows that
MED3000 is effective across all ED patient severities and achieves clinically
important efficacy at each time point up to and including 24 weeks.  Notably,
MED3000 helps men achieve first signs of an erection within 10 minutes
according to pre-determined statistical criteria agreed with the FDA. MED3000
has also demonstrated excellent safety in comparison with prescription oral
medication and as such has a very favourable benefit to risk profile making it
ideally suited to OTC classification throughout the USA."

 

Webcast

James Barder, Chief Executive Officer, and Ken James, Executive Director and
Head of R&D, will host a webcast to discuss the data at 10am BST, 31
August 2022, which can be found within the Investor Centre section of the
Futura company website at www.futuramedical.com.

 

1.      OTC - available without the need of a doctor's prescription

2.    Minimal Clinically Important Differences in the Erectile Function
Domain of the International Index of Erectile Function Scale Rosen et al

https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.960.9423&rep=rep1&type=pdf
(https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.960.9423&rep=rep1&type=pdf)

 

The information communicated in this announcement contains inside information
for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014
as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

-ENDS-

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: investor.relations@futuramedical.com
(mailto:Investor.relations@futuramedical.com)

Tel: +44 (0) 1483 685 670

www.futuramedical.com (http://www.futuramedical.com/)

Nominated Adviser and Sole Broker:

Liberum

Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings

Tel: +44 (0) 20 3100 2000

 

For media enquiries please contact:

 

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt

Email: futuramedical@optimumcomms.com

Tel: +44 (0)20 3922 0890

 

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 previously 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, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted
clinical trial endpoints in ED) with over 60% of patients experiencing a
clinically meaningful improvement in their ED.

MED3000 is CE marked in Europe and CA marked in the UK as a clinically
proven topical treatment for adult men with erectile dysfunction under the
brand Eroxon™ with a key claim of "Helps you get an erection within 10
minutes".

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

 

 

 

 

 

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