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(Alliance News) - Shares in Futura Medical PLC plunged more than 50% on Tuesday on news its phase 3 study of lead product MED2005 failed to meet its primary endpoint.
The pharmaceutical firm's shares were down 53% at 13.50 pence in London in afternoon trading.
The trial, FM57, investigated the efficacy and safety of MED2005 in 1,000 patients with mild, moderate and severe erectile dysfunction. The drug was given at three different doses of active ingredient glyceryl trinitrate, 0.2%, 0.4%, and 0.6%.
In the trial, both the placebo group and those taking MED2005 used Futura's transdermal DermaSys formulation, which delivers the drug through the skin.
While the three primary co-endpoints were achieved against baseline data for MED2005 and DermaSys, the placebo group with just DermaSys also achieved statistically significant and clinically meaningful top-line results - meaning the patients taking the actual MED2005 drug did not beat the placebo.
The co-primary endpoints were a patient's International Index of Erectile Function-Erectile Function Domain Score and the percentage of yes responses to questions 2 and 3 on the Sexual Encounter Profile questionnaire.
Futura claims the strong placebo performance could mean DermaSys itself, rather than MED2005, might be an effective erectile dysfunction treatment.
"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," said Futura.
The company also said this might actually be a faster route to market and present a "greater commercial opportunity".
Futura has also filed a new patent application which, if successful, could extend patent protection until 2039.
Chief Executive James Barder 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."
By Anna Farley; annafarley@alliancenews.com
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