Futura Medical PLC (LON:FUM), which is developing a gel that helps men with erectile dysfunction, has announced “encouraging” interim data from a pharmacokinetic study.
The definitive results will be used to guide a phase III clinical assessments of MED2002.
READ: Respected industry journal publishes data from phase II trial of Futura Medical’s MED2002 ED gel
Researchers are evaluating the dose of 0.2% glyceryl trinitrate (shortened to GTN) used previously, as well as assessing the potential of upping that 0.4%, 0.6% and 0.8% in order to maximise efficacy in two final-stage trials.
One of the key goals of the pharmacokinetic study is to demonstrate that the blood plasma concentrations of GTN of at least some of the higher doses fall within the concentrations of a US reference product, Nitrostat, which is out on the market and used to treat angina.
If it can demonstrate equivalence, Futura would be able to use the FDA 505(b)(2) route to regulatory approval.
This means that at least some of the safety information required for approval comes from studies not carried out by the company.
A total of 30 men have been dosed with 0.2%, 0.4% and 0.6%.
Futura said the 0.8% dose had similar but slightly higher levels of GTN in the blood plasma than Nitrostat.
The second phase of the pharmacokinetic study gets underway soon, assessing 10 men.
Chief executive James Barder said: “We are very encouraged by the interim data in this pharmacokinetic study and, importantly, the data supports our plans to include higher strength doses of MED2002 in our Phase III clinical studies.
“We expect the full results from the pharmacokinetic study in about a month's time when we will finalise the protocol of our Phase III studies."