(WebFG News) - Advanced transdermal technology-focussed healthcare company Futura Medical updated the market on the planned phase III trials for MED 2002, its topical gel for erectile dysfunction, on Thursday.
The AIM-traded firm said that, following the "excellent" results from its pharmacokinetic study of MED2002 announced on Wednesday, it commenced preparatory work on the first phase III efficacy trial with a target of first patient dosed by the end of September.
It said the first phase III trial would be a dose ranging, multicentre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically-applied glyceryl trinitrate.
The study, FM58, would recruit approximately 1,000 patients with mild, moderate or severe ED and compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2002 against that of placebo.
Futura said the trial would be conducted throughout Eastern Europe with a three-month study period for each patient.
The board said it was confident that the positive PK data published this month supported the decision to conduct phase III studies at higher doses than previously studied, and that 0.6% GTN was the maximum dose that would likely be considered suitable for the regulatory pathway in the US.
Additionally, Futura said it believed the PK study had improved the overall cost effectiveness and likely success of the phase III clinical studies, and enabled those studies to be run as efficiently as possible.
At present, the company said it did not intend to carry out further development work on the 0.8% GTN dose of MED2002 but, dependent on the long-term objectives of potential commercial partners, it could revisit that and other dose strengths in the future.
The company said its successful phase IIa study, FM53, previously showed a statistically significant improvement in erectile function for patients with mild and mild-to-moderate erectile dysfunction using a 0.2% GTN dose versus placebo.
By including doses up to three times the level used in FM53, the board said there was "significant potential" for improved efficacy to be demonstrated including in the more severe cases of erectile dysfunction.
Futura expected MED2002 would be well tolerated, even at the highest dose of 0.6% GTN to be used in the phase III trial, based on the recently-reported PK data where a low adverse effect profile across all doses was observed, including at 0.8% GTN.
Depending on the speed of regulatory approval and patient recruitment proceeding in line with reasonable expectations, the board anticipated the first patient would be dosed by the end of September, with the last patient dosed by the end of June 2019, and headline efficacy results by end of December 2019.
As part of the phase III trial, long term safety data would be recorded in compliance with international guidelines, and reported separately to the timelines outlined.
"We are excited to be moving forward with the first Phase III trial of MED2002," said Futura chief executive James Barder.
"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."
Barder said the potential for MED2002 as a safe, rapid and effective treatment for erectile dysfunction was "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."