Futura Medical (FUM:14.75p), a pharmaceutical company that is developing a portfolio of innovative products based on its proprietary, transdermal Dermasys drug delivery technology, is on track to release headline data by the year-end from its Phase III clinical study for flagship product MED2005, a breakthrough topical gel for erectile dysfunction (ED). The data will help facilitate ongoing discussions with commercial partners. The 1,000 patient study is being run across 60 centres in central and eastern Europe to ensure patients are recruited quickly and efficiently, and has the requisite regulatory and ethics clearance from all nine countries involved.
To put the size of the global market for Futura’s treatment into perspective, ED disrupts the lives of at least one in five men around the world, affecting the sexual and emotional health of 27m men and their partners in the US alone. However, there has been little innovation in ED treatments for over a decade and many patients continue to suffer dissatisfaction from existing treatments (oral inhibitors) especially those looking for a fast-acting treatment that can form part of sexual foreplay, or those that are contraindicated from using existing therapies. Indeed, at least 10 per cent of patients are unable to take oral inhibitors because they are on nitrate therapy, so would benefit from MED2005.
Bearing this in mind, in pharmacokinetic (PK) studies, MED2005 has shown to lead to a rapid rate of glyceryl trinitrate (GTN) absorption, with first detection in blood plasma in four to five minutes, reaching peak levels in the bloodstream within 10 to 12 minutes for all doses. These findings are consistent with a product that has shown a rapid onset of action in Futura’s Phase 2a study. Furthermore, there is a low GTN residue on the skin at five minutes even with a high 0.6 per cent GTN MED2005 dose, providing reassurance that there is likely to be minimal risk in transference of GTN to the sexual partner during intercourse, even at the higher doses.