Futura Announces Top-Line Results from MED2005 Phase 3 study in Erectile Dysfunction
- All arms met all primary endpoints against baseline, showing strong efficacy, safety, and rapid speed of onset
- However, MED2005 did not meet primary endpoints versus placebo
- Based on statistically significant, results compared against baseline, Futura intends to discuss a potential medical device regulatory approval pathway with the U.S. Food and Drug Administration
- Newly filed patent application has potential to extend protection of DermaSys® until 2039
GUILDFORD, England, Dec. 12, 2019 (GLOBE NEWSWIRE) -- 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 currently focused on sexual health and pain, today announced top-line results from the European Phase 3 study, “FM57” of its lead product candidate, MED2005, for the treatment of erectile dysfunction (ED).
All three primary co-primary endpoints (IIEF-EF, SEP2 and SEP3) were achieved against baseline data for MED2005 and DermaSys in addition to supporting secondary endpoints including efficacy, speed of onset, duration of action and patient meaningful differences.
The placebo used in the study, 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. While this placebo does not contain the active pharmaceutical ingredient, nitro glycerin (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.
“Although FM57 has not met the primary endpoints versus placebo, we believe the data demonstrating that DermaSys formulation alone achieved statistical significance compared with baseline for all the primary and key secondary endpoints is an interesting outcome that may enable an alternative pathway to regulatory approval,” said James Barder, Chief Executive Officer, Futura Medical. “We intend to discuss potential next steps with the U.S. Food and Drug Administration and will subsequently provide shareholders with an update on what we believe may be a new simpler and expected lower cost regulatory pathway.”
“The efficacy of the DermaSys product 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,” said Professor David Ralph, Consultant Urologist at University College London and past president of the European Society of Sexual Medicine. “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.”
The Phase 3 study investigated the efficacy and safety of 0.2%, 0.4% and 0.6% GTN doses of MED2005 in 1,000 mild, moderate and severe erectile dysfunction (“ED”) patients in Europe versus DermaSys alone. Patients were enrolled in 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’.
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. More than 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.
| Primary Endpoints | DermaSys® (placebo) | P-values | 0.6mg (0.2%) MED2005 | P-values | 1.2mg (0.4%) MED2005 | P-values | 1.8mg (0.6%) MED2005 | P-values |
| IIEF-EF Domain | 3.60 | <0.001 | 3.39 | <0.001 | 3.42 | <0.001 | 3.66 | <0.001 |
| SEP2 (Were you able to insert your penis into your partner’s vagina) | 13.8% | <0.001 | 9% | <0.001 | 13.27% | <0.001 | 10.67% | <0.001 |
| SEP3 (Did your erection last long enough for you to have successful intercourse) | 23.16% | <0.001 | 20.76% | <0.001 | 22.63% | <0.001 | 23.27% | <0.001 |
Safety and tolerability data were positive with no serious adverse events and a favorable overall side effect profile across all doses against baseline affirming data from the prior Phase 2a study.
“All formulations tested in FM57, including the control product DermaSys®, have demonstrated positive and statistically significant efficacy results against baseline data together with an excellent safety profile,” said Dr. Yacov Reisman, Consultant Urologist and president of the European Society of Sexual Medicine. “The DermaSys® product will be of high interest to the Medical Community for those patients who seeking a 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.”
Ken James, Executive Director and Head of R&D at Futura 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.”
Webcast
James Barder, Chief Executive Officer, and Ken James, Executive Director and Head of R&D, hosted a webcast to discuss the data. It is available within the Investor Centre section of the Futura company website at .
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email:
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Finn Partners
Erich Sandoval
Email:
Tel:
Notes to editors:
About Futura’s Phase 3 Study Design and Top Line Results
The Phase 3 study was a dose-ranging, randomised, double blind, placebo controlled, home use, parallel group study evaluating treatment of 1,000 patients with mild, moderate and severe ED across nine countries and 60 centres in Central and Eastern Europe. The study compared the efficacy of 0.2%, 0.4% and 0.6% GTN doses in MED2005, a topically applied DermaSys formulation, against that of placebo with an initial three-month, blinded, study period for each patient. Highlights from that data are hereby reported.
The three co-primary endpoints used to demonstrate the efficacy of MED2005 versus placebo in male subjects self-diagnosed with ED are FDA preferred endpoints used in all recent FDA approvals for PDE5i’s (Cialis, Levitra and Stendra):
- International Index of Erectile Function-Erectile Function Domain Score (IIEF-EF): this is a score up to 30 whereby 10 or less indicates severe ED, 11-17 indicates moderate ED, 18-25 indicates mild ED and 26-30 is normal functioning.
- Sexual Encounter Profile (SEP) questionnaire evaluating sexual function where higher scores indicate better erectile function, measuring the change during treatment in the percentage of "yes" responses to SEP question two and three. SEP Q2 asks “Were you able to insert your penis into your partner's vagina?” and SEP Q3 asks "Did your erection last long enough for you to have successful intercourse?"
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® drug delivery technology. These products are optimized for clinical efficacy, safety, administration and patient convenience and 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 maximize product differentiation and value creation whilst minimizing risk.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.
