26th Apr 2018 13:53
LONDON (Alliance News) - Healthcare firm Futura Medical PLC said Thursday it has started preparing for a phase III trial for its proposed erectile dysfunction gel MED 2002.
This trial follows what it said were "excellent" results from its pharmacokinetic trial, which it announced Wednesday.
Futura hopes to have dosed the first patient in the new trial by the end of September. It will use around 1,000 patients in eastern Europe and compare three doses of varying strength against a placebo.
Futura is confident prior data merits a phase III trial at higher doses than previously studied, and the maximum dose is at the limit of what would be considered suitable by regulators in the US.
Futura expects the drug to be well tolerated, even at the highest dose, based on recent data.
Timeline-wise, the company hopes to have the last patient dosed by June next year, with headline efficacy results published in December 2019.
Chief Executive James Barder said: "We are excited to be moving forward with the first phase III trial of MED2002. Following the excellent PK study results reported earlier this week, we are now confident that the upcoming studies will be run as efficiently and cost effectively as possible.
"The potential for MED2002 as a safe, rapid and effective treatment for erectile dysfunction is huge. We are pleased to report that discussions regarding commercialisation are progressing and we look forward to providing shareholders with a further update at the appropriate time."
Shares were down 1.6% on Thursday at 34.70 pence each.
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