MED3000: more detail on FM57 results
Lighthouse | 2 April 2020
Trinity Delta view: The analysis of the FM57 data shows a remarkably consistent outcomes across all treatment groups and supports the view that MED3000 is an effective and safe therapy for ED. Regulatory submissions for approval of MED3000 as a medical device opens a potentially faster route to market, with probably no further clinical work required for Europe and (possibly) a small study for the US. Although difficult to compare without direct trials, the efficacy seen would suggest an activity approaching that of oral PDE5s such as tadalafil (Cialis), but with a faster onset of action and fewer side-effects. As we highlighted previously, significant unknowns remain, but the outlook is increasingly positive. We suspended our forecasts and valuation at the time of the top line FM57 results and aim to reinstate them as soon as practicable.
2 April 2020
Futura Medical is an R&D driven small pharma company, with a novel DermaSys transdermal delivery platform. The lead programme, MED3000, a topically applied gel, is being developed for erectile dysfunction (ED). A pain relief gel, TPR100, is awaiting UK approval.
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