Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology currently focused on sexual health and pain, is pleased to announce that John Clarke, Chairman, will provide the following update at the Company's Annual General Meeting which is being held at 10am BST later today in London.
MED2005 -Topical gel for erectile dysfunction ("ED")
On 19 June 2019, the Company announced the completion of patient recruitment for the first European Phase 3 study, "FM57", of MED2005. The 1,000 patient study for the treatment of mild, moderate and severe erectile dysfunction ("ED") includes approximately 60 centres across Central and Eastern Europe. Futura remains on track to deliver headline data by the end of 2019.
Planning for a second, confirmatory Phase 3 study for MED2005 has been undertaken, after extensive dialogue with regulators and KOLs in the field of ED. This study will incorporate a US patient cohort which is expected to facilitate regulatory filing in the US. This second study will be informed by the receipt and analysis of the first Phase 3 data. The Company plans to shortly commence pre-recruitment start-up activities, such as Regulatory and Ethics approvals which can take up to six months to complete to ensure recruitment is not delayed. Patient recruitment will start as soon as possible after the first Phase 3 study data analysis is complete.
It is usual for two Phase 3 studies to be required for regulatory filing. However, depending on data from the first European Phase 3 study, Futura may explore filing MED2005 with regulatory bodies in Europe with one Phase 3 study which could occur during 2020. The US FDA has been clear that two studies are required, and filing will await results from the second Phase 3 study.
TPR100 - Topical gel for pain relief
The Company's novel topical pain relief gel TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK's largest consumer healthcare companies and a subsidiary of STADA AG. In response to Thornton & Ross's marketing authorisation application filed in July 2018, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has raised a number of questions requiring additional lab work to be conducted. This work is well advanced, and we expect Thornton & Ross to respond to the MHRA in September with regulatory opinion before the end of the year.
The Company has received expressions of interest from a number of parties to enable Futura to expand the geographical reach of TPR100. Futura is awaiting regulatory authorisation in the UK before progressing further.
Futura's Chairman, John Clarke, commented: "We continue to make good progress in the development and commercialisation of our pipeline of product opportunities. We are pleased to have completed recruitment for the first European Phase 3 study of MED2005 and eagerly await the Phase 3 data read-out at the end of the year. We look forward to updating the market on Futura's developments during 2019, which I expect to be a year of very significant progress for the Company."