Investors reading today’s clinical trial result announcement from Verona Pharma – at least those who got beyond the “encouraging topline data” claim in its headline – might be excused for thinking that the biggest problem is that ensifentrine failed. In fact, the asset faces a more fundamental crisis, namely that it has been in development for so long that it has only another year or two of patent life remaining. This likely explains why ensifentrine (until recently known by the lab code RLP554) is still unpartnered, a situation that must be reversed if a large pivotal study in respiratory disease is to take place. The phase II COPD trial that failed today added ensifentrine on top of Boehringer Ingelheim’s LAMA/LABA combo Stiolto Respimat, and was to have backed up last year’s success in a mid-stage study that required subjects to forgo LABAs (Verona’s transformation clears its first hurdle, March 26, 2018). One concern with that earlier trial was the lack of a dose response; if anything today’s failure will exacerbate such fears, as the numerical success Verona claims concerns 1.5mg – the lower of two doses tested. Undaunted, the group called the data “clinically meaningful and unprecedented”; its stock fell 30% this morning.
|Selected ensifentrine studies in COPD|
|NCT03443414||Versus placebo (no LABA use allowed)||0.75mg, 1.5mg, 3.0mg & 6.0mg doses all hit day-4 FEV1 endpoint|
|NCT03028142||On top of Spiriva||1.5mg & 6.0mg doses hit day-3 FEV1 endpoint; 6.0mg hits avg FEV1 co-primary|
|NCT03673670||On top of Stiolto Respimat||1.5mg & 6.0mg doses fail day-3 FEV1 endpoint; numerical benefit claimed for 1.5mg|