Futura Announces Top Line Results from MED2005 Phase 3 study
· In FM57, all arms met all primary endpoints against baseline, showing strong efficacy, excellent safety, rapid speed of onset
· However, in FM57, MED2005 did not meet primary endpoints versus placebo
· Surprising but highly statistically significant, results compared against baseline provides the company the possibility of a simpler regulatory pathway, as a medical device
· New patent application filed which has the potential, if successful, to extend protection until 2039
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, announces its top line results from the European Phase 3 study, "FM57" of lead product, MED2005 for the treatment of erectile dysfunction ("ED).
Efficacy
The Phase 3 study investigated the efficacy and safety of 0.2%, 0.4% and 0.6% glyceryl trinitrate ("GTN") doses of MED2005 in 1,000 mild, moderate and severe erectile dysfunction ("ED") patients in Europe versus DermaSys alone. Patients being enrolled into the FM57 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'.
All three primary co-primary endpoints (IIEF-EF, SEP2 and SEP3) were achieved against baseline data for MED2005 and DermaSys in addition to important, supporting secondary endpoints in terms of efficacy, speed of onset, duration of action and patient meaningful differences.
However, the placebo used in the study which was Futura's proprietary transdermal DermaSys formulation also demonstrated statistically significant and clinically meaningful top line results meaning that FM57 did not meet primary endpoints versus placebo. Whilst this placebo does not contain the active pharmaceutical ingredient, GTN, used in MED2005, it uses the key ingredients that constitute DermaSys' proven transdermal technology and was shown to be as effective in the treatment of ED as the active doses.
Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients with a highly favourable overall side effect profile across all doses against baseline affirming data from the prior Phase 2a study.
Data demonstrated a statistically significant improvement in erectile function across 'pooled' patient severities (mild, moderate, and severe) of erectile dysfunction using 0.2%, 0.4% and 0.6% GTN doses and DermaSys against baseline with over 60% of all patient's experiences meaningful difference in improvement of their erections using industry standard assessment techniques recognised and accepted by leading ED KOLs. Over 60% of patients saw a speed of onset within 10 minutes of application, substantially faster than sildenafil with significant benefits for spontaneous rather than pre-planned sexual intercourse.
Next Steps
The surprising yet highly statistically significant results for the DermaSys control arm (placebo) compared against baseline provides the company with a new, potentially simpler regulatory pathway for DermaSys as a medical device as compared with MED2005 as a drug, yet with strong clinically proven claims for the treatment of erectile dysfunction. Moreover, and subject to identifying a regulatory pathway, the Board believes this may provide a faster route to market and a greater commercial opportunity with the opportunity to provide a clinically proven treatment for many patients currently contraindicated from using existing medications such as nitrates and alpha blockers. The Company has also filed a new patent application which has the potential, if successful, to extend protection until 2039.
James Barder, Chief Executive Officer, Futura Medical said: "While we are surprised that FM57 has not met the primary endpoints versus placebo, we are excited that DermaSys alone has achieved such statistical significance in meeting all the primary endpoints against the baseline and key secondary endpoints using validated and globally accepted measurement tools. We now believe this supports the potential for a simpler route to regulatory approval for the proprietary DermaSys formulation as a clinically proven treatment for erectile dysfunction."
We will provide shareholders with an update on what we believe will be a new simpler and expected lower cost regulatory pathway as soon as possible."
Ken James, Executive Director and Head of R&D added. "It is encouraging to see that the DermaSys formulation is highly effective across all ED patient severities, despite MED2005 not having met primary endpoints against the control arm. We believe it has the potential to be a significant innovation in the $5.6 billion erectile dysfunction global market especially for patients looking for a rapid speed of onset and spontaneity, with an excellent adverse event profile."
Professor David Ralph, Consultant Urologist at University College London and past president of the European Society of Sexual Medicine commented on the results. "The efficacy of the DermaSys® product is remarkable and approaches the efficacy of current first line therapy but with significantly lower adverse events. With topical application, it will be of particular appeal to patients who want a fast onset of action. Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. It can also be used in conjunction with other ED products to improve overall efficacy to patients. As such the product will be of great interest to the medical community."
Dr Yacov Reisman, Consultant Urologist and president of the European Society of Sexual Medicine commented on the results. "All formulations tested in FM57, including the control product DermaSys®, have demonstrated positive and statistically significant efficacy results against baseline data together with excellent safety profile. The DermaSys® product will be of high interest to the Medical Community for those patients who seeking a very rapid onset of action and a very low side-effect profile. It will likely find use in the substantial number of patients, especially those with ED of a mild to moderate nature and those patients who are contraindicated for use with existing products."