Phase 2 trial of Falkieri (esketamine DPI) in TR bipolar depression
We are very happy to announce that our client Celon Pharma S.A. published positive top-line results from our Phase II study of Falkieri (proprietary esketamine dry powder inhalation) in the acute phase of treatment-resistant bipolar depression.
Positive results were also observed for multiple secondary endpoints with the most impressive remission rates at Week 2 achieving levels of 43-46% on active treatment vs. 9% in the placebo arm.
Importantly, the manic switch was not seen in patients administered Falkieri in the study, being the first such observation demonstrated in esketamine trials. Mania induction is a well-recognized risk factor of antidepressant therapeutics in bipolar depression.
Full data from the Phase 2 trial will be presented at an upcoming medical conference, meanwhile, you can take a look at the presentation from the Meeting linked below.
It’s a huge success and we are hoping that thanks to the work and involvement from all sides we are going to be able to improve the lives of people suffering from this illness.