Celon Pharma Announces Positive Falkieri Phase II Results in Treatment-Resistant Bipolar Depression
January 09, 2021 at 12:46 am IST
Share
Celon Pharma announced positive top-line results from a Phase II study of Falkieri (proprietary esketamine dry powder inhalation) in acute phase of treatment-resistant bipolar depression. In the trial, Falkieri met the primary endpoint with statistically significant reductions in MADRS total score compared to placebo at Week 2 in all tested doses, with a dose-response trend. MADRS placebo-subtracted differences were -5.9 (95% CI: -10.2 to -1.5; p=0.009) in the 24 mg dose; -6.7 (95% CI:- 11.1 to -2.2; p=0.004) in the 36 mg dose and -8.2 (95% CI: -12.6 to-3.7; p<0.001) in the 48 mg dose. This was a randomized, double-blind, placebo-controlled, multi-center study of 88 adult patients with an inadequate response to at least two evidence-based treatment lines in bipolar depression. Patients were allocated to receive adjunctive treatment of either 24 mg, 36 mg, or 48 mg of Falkieri or placebo twice weekly for two weeks. Patients randomized to Falkieri treatment also demonstrated significant improvement in another depressive scale - HDRS at all tested doses, with dose-response effect trend. 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. In this Phase 2 study, Falkieri exhibited good safety and tolerability profile. No discontinuations due to adverse events were observed. There were also no serious adverse events (SAEs) occurred in the study. Dissociation was transient, self-limiting and mild in intensity achieving its peak at 45 minutes after drug administration. No sedation was recorded. Importantly, manic switch was not seen in patients administered Falkieri in the study, being 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.
Celon Pharma SA is a Poland-based company primarily engaged in the pharmaceuticals manufacture. The Company focuses on research, development and production of generic drugs for cancer, neurological diseases, diabetes and other metabolic disorders treatment, among others. Its products portfolio comprises pills, such as Aromek, Bosentan Celon, Donepex, Ketrel, Lazivir and Valzek, as well as inhalation powder, such as Salmex. The Company's research center develops pharmaceuticals within a number of therapeutic areas, including oncology, neurology, as well as inflammatory and metabolic diseases. The Company is a subsidiary of Glatton sp z o o.