MED2002 Regulatory Update
31 May 2017
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to provide the following update on its discussions with US and UK regulatory authorities on the clinical trial requirements and regulatory pathway for MED2002, the Company’s topical gel for erectile dysfunction (“ED”).
Summary and Highlights
- Written responses received from regulators (the US FDA and the UK MHRA) on regulatory pathway for MED2002
- Responses support the Company’s expectations, including on timing for regulatory submissions for marketing authorisations, anticipated in Q2 2019 following data from studies to be initiated in Q4 2017
- Recommendations to evaluate at higher doses to optimise efficacy across the spectrum of all ED patients, as well as to obtain limited additional safety data
The planned Phase III programme follow the successful clinical results announced on 7 September 2016, confirming MED202 had met its primary endpoint and showed efficacy, safety and speed of onset. MED2002’s rapid onset of action means that it has the potential to be the world’s fastest-acting treatment for ED.
James Barder, Futura’s Chief Executive, commented: “We are delighted by the constructive feedback provided on the remaining development pathway for MED2002, our topical gel for ED, from both the US and UK regulatory authorities. We believe that to have the remaining development programme aligned with the authorities’ suggestions, and with no expected impact on overall timelines, this is an excellent outcome and should provide reassurance for shareholders and prospective license partners alike. We look forward to updating shareholders further on the development and commercialisation of a product that has the potential to be the world’s fastest-acting treatment for ED.”
Further details on the regulatory feedback and the Company’s development strategy for MED2002 are provided below:
Futura confirms that it has now received written responses following constructive meetings with the US Food & Drug Administration (“FDA”) and the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”). There was a broad consensus from both regulatory authorities on the development pathway for MED2002 which validates the Company’s previously disclosed target of making regulatory submissions in US and certain EU territories in H1 2019.
Both the FDA and MHRA confirmed filing routes by which the Company can make use of the extensive pre-existing safety data on the active ingredient in MED 2002, glyceryl trinitrate (“GTN”), which has already been approved in other indications and is well characterised. A limited amount of additional data will be required to confirm that the unique application of the MED2002 gel to the penis and the limited transference of the active ingredient to the sexual partner do not present a safety issue. As anticipated, MED2002’s US filing will be via a 505(b)(2) investigational new drug application and in Europe via an Article 8.3 of Directive 2001/83/EC (as amended).
The authorities gave their support in principle to the Company’s proposal to conduct a pivotal Phase III, placebo controlled, parallel group, multi-centre clinical study. In addition, they urged the Company to evaluate higher doses in addition to those originally proposed of 0.2% and 0.4% to optimise efficacy across the spectrum of all ED patients. The strategy of providing a range of dose strengths is already followed by existing oral ED treatments.
The Company intends to adopt this recommendation and will conduct two Phase III studies, but with differing dosage protocols to address the suggestions made by authorities whilst optimising the chances of clinical success. The studies will also include a cohort of ED patients taking other medication containing nitrates, as these patients are currently contraindicated from taking existing oral ED treatments.
The authorities also gave their support to Futura’s proposal to conduct a pharmacokinetic safety study to compare GTN blood plasma levels of MED2002 with existing GTN drugs to support the proposed abridged filings and confirm the expected low level of GTN transference to the sexual partner. The latter was evidenced through the extremely low side effect profile observed in women in the Company’s earlier study which concluded in 2016.
The timelines for the remaining study programme remain in line with those outlined in the Company’s preliminary results announced on 23 March 2017, with the studies expected to begin with first patient recruitment in Q4 2017 and regulatory submissions for marketing authorisation expected to be made in Q2 2019. A further regulatory meeting with the MEB, the Netherlands regulatory authority, is also planned ahead of recruitment of the first patient into the ongoing clinical trial programme.
For further information please contact:
Aubrey Powell / Liz Yong
Tel: +44 (0) 20 7496 3000
For media enquiries please contact:
Mark Court / Sophie Wills /
Stephanie Watson / Tilly Abraham
Tel: +44 (0) 20 7466 5000
Notes to editors:
About 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.