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(Alliance News) - Shares jumped in Futura Medical PLC on Monday after the pharmaceutical company reached an agreement with the US Food & Drug Administration for further studies into its erectile disfunction treatment.
Shares in the Surrey-based pharmaceutical company rose 54% to 71.00 pence on Monday in London.
The FDA agreed to a confirmatory clinical study for MED3000 to be conducted. The study will be known as FM71. The
FM71 will be conducted before formal regulatory submission as a DeNovo Medical Device.
FM71 will provide supplementary efficacy data to the prior FM57 study, and will be smaller in size with 100 patients compared to FM57's 1,000 patients, due to no placebo cohort being required.
Detailed planning for the start of the study has being with first patient dosing expected in the second half.
In order to reassure the FDA that the efficacy does not diminish over a longer period of time, FM71 will have a duration of six months, compared to FM57's three months, and has two co-primary endpoints to measure the clinically meaningful effect.
Using the International Index of Erectile Function, the first endpoint will measure the IIEF-EF change from baseline, and the second endpoint requires a minimum change in improvements from the baseline of four IIEF-EF units.
"We are pleased to have reached agreement with the FDA on the clinical trial protocol for FM71 which follows closely the positive recommendation for approval from the Notified Body on the European submission for MED3000, and the recently announced Joint Collaboration agreement for the China and South East Asia region. These key milestones are indicative of the rapid progress we have made in the last few months on our journey to fully commercialise MED3000," said Chief Executive James Barder.
By Dayo Laniyan; dayolaniyan@alliancenews.com
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