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Futura Medical says it may have found simpler route to regulatory approval after surprise phase III results

The delivery mechanism for the company's erectile dysfunction drug appeared to have a clinically significant impact on men with the condition

Futura Medical PLC -

Futura Medical PLC (LON:FUM) believes it has found a "simpler route to regulatory approval” following a surprising read-out from the phase III clinical trial of its erectile dysfunction gel.

These were nuanced results. For while MED2005 showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.

Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever.

However, in the Futura FM57 clinical assessment, researchers used DermaSys, developed by the company to deliver the active ingredient glyceryl trinitrate, or GTN for short.

As Futura said the results from the control group were highly statistically significant this would tend to rule out a small lift sometimes observed called the placebo effect.

Scored well

The outcome meant that while MED2005 scored well on most trial elements (efficacy, safety, and speed of onset) it failed to meet its clinical endpoint against the placebo gel.

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."

The drug is being developed for men with erectile dysfunction that can’t take the current crop of blue pills because of their side effects.

Binary response  

The ‘nuanced’ results and upbeat commentary from the company notwithstanding, the market response was a fairly binary one with the shares more than halving in value to 11.4p.

Broker Liberum, keeping its price target at 60p, made this observation: “Although the data are not unequivocally positive, there is a strong possibility of regulatory approval within our previously expected timeline, if not before, while the commercial outlook is unchanged.”

It reckons we should gain more clarity “on the pathway to approval” in the first quarter of next year – after its meeting with the US Food & Drug Administration.

----Adds broker commentary---

Quick facts: Futura Medical PLC

Price: 15 GBX

AIM:FUM
Market: AIM
Market Cap: £36.84 m
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