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, an investigational therapy for the treatment of
erectile dysfunction (“ED”).
Key highlights about the FM71 study:
- Co-primary endpoints that were agreed to with the U.S. Food and
Drug Administration (FDA) were 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 favorable side-effect profile.
- Futura is on track to file its dossier with the FDA by the end
of September, targeting marketing authorization by the FDA of
MED3000 in Q1 2023 as the first major ED treatment available
over-the-counter (OTC) classification I.
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 review for MED3000 and continue to target US OTC FDA
marketing authorization 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 to with the FDA. MED3000
has also demonstrated excellent safety in comparison with
prescription oral medication, and as such, has a very favorable
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 pre-recorded webcast to
discuss the data at 10am BST, 31 August 2022 (5am ET), which can be
found within the Investor Centre section of the Futura company
website at www.futuramedical.com.
MED3000 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-user study.
Accumulated MED3000 clinical data demonstrates that it may be a
treatment option with a rapid onset of action and favorable 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 may provide 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-center, randomized, 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 to with the FDA as a confirmatory clinical trial for
the US regulatory dossier for MED3000 which the company continues
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 the 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
recognized International Index of Erectile Function-Erectile
Function (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 al2, 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 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 favorable overall side-effect profile. Of particular note is
that 19.1% of tadalafil users experienced a headache on at least
one occasion while 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 (2 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 favorable side effect profile
compared to tadalafil.
Comparison of FM71 with previously conducted Phase 3 clinical
trial, FM57
Data from 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 authorization of MED3000 by the FDA remains on
course for Q1 2023.
- OTC – available without the need of a doctor’s
prescription
- 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
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.
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 commercialization strategies are designed
to maximise product differentiation and value creation while
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-center, randomized, 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
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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 Phil Walker/
Richard Lindley/ Ben Cryer/ Kane Collings Tel: +44 (0) 20 3100
2000
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