Futura Medical has presented details of the pivotal Phase III study (FM57) results for its lead compound, MED2005. All doses achieved all primary endpoints against baseline (p<0.001) throughout the 12-week period, with secondary endpoints also being met. However, the placebo arm, consisting of the DermaSys formulation alone, achieved similarly impressive results. Dose-dependent variation in side-effects should allay fears that administration errors may be to blame. These data suggest that the DermaSys gel alone has a significant clinical effect across the three severities of ED (Erectile Dysfunction) examined. Clearly the data needs to be digested, but this would appear to open up new opportunities, especially in terms of regulatory pathways, patent life, and commercial potential. Until we have greater visibility, we suspend our valuation and forecasts; for context we valued Futura Medical at £127m (62p a share).
11 Dec 2019
Remarkable data from pivotal trial opens new possibilities
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Remarkable data from pivotal trial opens new possibilities
Futura Medical plc (FUM:LON) | 35.7 -0.1 (-0.6%) | Mkt Cap: 107.7m
- Published:
11 Dec 2019 -
Author:
Lala Gregorek -
Pages:
8
Futura Medical has presented details of the pivotal Phase III study (FM57) results for its lead compound, MED2005. All doses achieved all primary endpoints against baseline (p<0.001) throughout the 12-week period, with secondary endpoints also being met. However, the placebo arm, consisting of the DermaSys formulation alone, achieved similarly impressive results. Dose-dependent variation in side-effects should allay fears that administration errors may be to blame. These data suggest that the DermaSys gel alone has a significant clinical effect across the three severities of ED (Erectile Dysfunction) examined. Clearly the data needs to be digested, but this would appear to open up new opportunities, especially in terms of regulatory pathways, patent life, and commercial potential. Until we have greater visibility, we suspend our valuation and forecasts; for context we valued Futura Medical at £127m (62p a share).