Positive Interim Data from MED2002 PK study
13 March 2018
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce positive interim data from the pharmacokinetic ("PK") study that forms the initial stage in the Phase III programme of MED2002, the Company's topical gel for erectile dysfunction ("ED").
The PK study, which commenced in November 2017, is evaluating the dose of 0.2% glyceryl trinitrate ("GTN") used in the previously reported successful Phase II clinical study, and higher doses of 0.4%, 0.6% and 0.8% to assess their suitability for maximising efficacy in the two planned Phase III studies.
One of the key goals of the PK study is to demonstrate that the blood plasma concentrations of GTN of at least some of the higher doses fall within the plasma concentrations of a US reference product, Nitrostat®, which is used to treat angina. Demonstrating this equivalence will enable the Company to use the FDA 505(b)(2) route to regulatory approval where at least some of the safety information required for approval comes from studies not conducted by or for Futura.
We are pleased to report that in this phase of the study in 30 subjects the 0.2%, 0.4% and 0.6% doses met this requirement. The 0.8% dose had similar but slightly higher levels of GTN in the blood plasma than Nitrostat; this and other data will be further evaluated in the second phase of the PK study before the Company decides the final doses to be included in the first Phase III study. Additionally, as the dose of MED2002 was increased, the plasma concentrations increased, demonstrating that absorption occurs in a predictable and reliable manner, thereby providing further safety reassurance and underlining the potency and versatility of Futura's DermaSys® transdermal technology.
Adverse events were also monitored during this phase of the study and all four doses were well tolerated. In particular, the level of headache (the main side effect normally seen) between each different MED2002 dose and Nitrostat was broadly similar, mostly being mild and self-limiting.
The second phase of the PK study in 10 subjects commences shortly. This will evaluate how much GTN is left on the exterior of the penis 5 minutes after application and therefore inform how much transfer to the partner may occur during intercourse. This phase also assesses an intravenous dose of GTN to further demonstrate that MED2002 delivered topically has a large margin of safety. This phase is expected to be completed in about one month, after which we will provide a further update.
James Barder, Chief Executive of Futura Medical, said: "We are very encouraged by the interim data in this PK study and, importantly, the data supports our plans to include higher strength doses of MED2002 in our Phase III clinical studies. We expect the full results from the PK study in about a month's time when we will finalise the protocol of our Phase III studies."
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Aubrey Powell / Liz Yong / Thomas Smale
Tel: +44 (0) 20 7496 3000
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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.