Futura Medical Regulatory News (FUM)

Futura Medical plc

("Futura" or "the Company")

MED2002: PK Study Commences

Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, announces that recruitment has commenced for the Company's pharmacokinetic ("PK") study of MED2002, Futura's novel gel for the treatment of erectile dysfunction ("ED").

Data from the PK study in 40 healthy subjects, which represents the initial step in Futura's Phase III programme for MED2002, will assist in determining the dosages to be used in two Phase III studies, which will begin next year as soon as practicable after the completion of the PK study. 

The PK study will check the tolerance of subjects to a range of doses of MED2002 including higher doses than the dose used in the earlier efficacy study, the results of which were announced on 7 September 2016 and will also compare MED2002's safety profile against an approved angina treatment with the same active pharmaceutical ingredient.

The PK study will enable the exclusion of unacceptably high doses in the Phase III studies and provide additional safety data to support the proposed US regulatory pathway of a 505(b)(2) filing. Subject enrolment in the PK study is expected to be completed in early Q1 2018 and the results are expected to be available by the end of Q1 2018.

James Barder, Futura's Chief Executive, said: "The start of this PK study is of great significance for Futura as it marks the beginning of our Phase III programme for MED2002, our novel gel for the treatment of erectile dysfunction. By pre-screening formulations at a number of dosage strengths, the PK study will enable the Phase III studies to be run as expeditiously and cost effectively as possible.

"MED2002 has huge potential as a prescription medicine. This potential was highlighted by recent market research announced in October 2017, which found that more than 60 per cent of physicians in the US consider MED2002 to be an improvement over current ED therapies."

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Notes to Editors

Futura Medical plc

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.

www.futuramedical.com