Futura Medical PLC (LON:FUM) said it has dosed the first patient in its phase III clinical study of MED2002, a gel used to treat erectile dysfunction.
Headline data from the trial is expected next year. MED2002 is being developed as a rapid onset version of pills such as Viagra and Cialis. It works without side-effects such as headaches.
WATCH: Futura Medical doses first patient in phase III study
An earlier phase II assessment of Futura’s glyceryl trinitrate proved its efficacy, safety and a rapid speed of onset.
Randomised study
The current study is a randomised, double-blind and placebo-controlled, which means half the trial group receive a substance with no therapeutic value.
Only at the end of the assessment will researchers know which cohort received the active gel.
Different doses of MED2002 will be used to find the optimum application.
Chief executive James Barder said the enrolment of the first person to the phase III study was a “major milestone”.
"Futura is now in a position to build value by progressing the development of MED2002 through its planned phase III studies, and we are excited to be moving closer to bringing an innovative, highly differentiated ED [erectile dysfunction] product to market that could help the many ED patients whose needs are not met by current treatments."