Futura Medical PLC (LON:FUM) confirmed it will deliver the results from its phase III trial for a fast-acting gel for erectile dysfunction (ED) by the end of the year, a milestone which expects to be a “major value inflection point”.
The first of two studies of MED2005 got underway in October treating 1,000 men at 60 centres across Europe. Headline data should be released towards the back-end of 2019, the company said.
Planning for a second, confirmatory final-phase analysis has been undertaken after “extensive dialogue" with regulators and opinion leaders, investors were told.
It will incorporate a US patient group, which is expected to allow Futura to make a regulatory filing in the US. It said “discussions continue” with potential commercial partners, though nothing is likely to be concluded until it has the phase III trial results are public.
The update came alongside prelims from the healthcare business, which sharpened its focus last year to concentrate on two potential big sellers - MED2005, the ED treatment, and TPR100, a topical non-steroidal anti-inflammatory and pain killer.
Thornton & Ross, a subsidiary of German pharma STADA, is seeking UK marketing approval for the latter. In its update, Futura said it is in “ongoing discussions” with several other potential distribution partners, but added: “Any further licensing deals are expected to be after UK regulatory approval.”
Turning to the financials, the business posted a £5.89mln loss for the year ended December 31. More importantly, having raised £5.85mln last November (and with cash resources of £9.16mln at the year-end), it has the financial runway to see it through to the data readout for its ED breakthrough.