07:00 Tue 13 Mar 2018
Futura Medical PLC - Positive Interim Data from MED2002 PK study
For immediate release |
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("Futura" or the "Company")
Positive Interim Data from MED2002 PK study
The PK study, which commenced in
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
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.
For any further information please contact:
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Tel: +44 (0)1483 685 670 |
mail to: james.barder@futuramedical.com |
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N+1 Singer (Nominated Adviser and Broker) |
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Tel:+44 (0) 20 7496 3000 |
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For media enquiries please contact:
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Buchanan |
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Mark Court / |
Tel: +44 (0)20 7466 5000 |
Notes to Editors
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