LONDON (ShareCast) - (Sharecast News) - Pharmaceutical company Futura Medical announced the completion of patient recruitment for the first European phase 3 study of MED2005, 'FM57', on Wednesday, adding that it remained on track to deliver headline data by the end of 2019.
The AIM-traded firm said FM57 had completed recruitment of more than 1,000 patients in the study for the treatment of mild, moderate and severe erectile dysfunction.

It said the study included around 60 centres across central and eastern Europe, and would compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2005 against that of placebo, with an initial three-month study period for each patient.

FM57's protocol incorporated feedback received from key opinion leaders in erectile dysfunction, the US and EU regulatory agencies, as well as potential commercial partners, to increase the chances of regulatory approval as well as optimising the commercial value.

"We are extremely pleased to complete recruitment of over 1,000 patients for the first European Phase 3 study, 'FM57', of MED2005, within our expected timelines and budget and I would like to thank all parties involved in reaching this important milestone," said Futura Medical chief executive officer James Barder.

"The company's focus is now on the Phase 3 data read-out at the end of the year, which we hope will significantly clinically de-risk MED2005, and help provide commercial partners with greater certainty around the potential opportunity it presents."

Futura Medical said the potential market for such a product was "large", with potential peak sales in excess of $1bn.

It said that if MED2005 was approved, there was an estimated $560m prescription-only market potential, and an estimated incremental $660m+ market potential as an over-the-counter product, in markets where such a move was possible.

The company said its main focus was to deliver phase 3 double-blind headline data by the end of 2019, given it remained a "key value inflection point" for the firm, with the firm continuing discussions with a number of interested commercial partners for the out-licensing of MED2005.

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