Intra-celluar’s lumateperone is finally to be submitted to the FDA for approval in bipolar disorder after the company reported positive pivotal data with the higher dose when used as an adjunct treatment. Shares rocketed 60% in early trading this morning. The result could reassure investors after mixed data previously; one trial of lumateperone monotherapy was positive while the other failed, which the company blamed on a high placebo response. Efficacy-wise the positive adjunct and monotherapy data appear to be on a par with results seen with the older atypical antipsychotics Latuda and Abilify, with the usual caveats over comparing data from different trials. But lumateperone looks to have the edge in terms of safety: rates of extrapyramidal symptoms and changes in weight were similar between drug and placebo. Intra-cellular plans to file the project in the adjunct and monotherapy settings for both type I and II disease by the end of the year. Should the FDA only approve the adjunct use, another monotherapy study, called 403, is ongoing and could serve as a back-up if positive. Bipolar is a valuable indication, accounting for half of lumateperone’s $2bn sales forecast for 2026, according to EvaluatePharma consensus. The other half come from schizophrenia, where the product was approved as Caplyta last year.
|Data from Intra-cellular's phase III trials in bipolar disorder (placebo-adjusted change from baseline in MADRS total score)|
|Study 402 (global)||Study 404 (global)||Study 401 (US only)||Study 403 (global)|
|Lumateperone 42mg||2.4 points
|1.0 point (not stat sig)||Primary completion June 2021|
|Lumateperone 28mg||Not stat sig||N/A||-0.8 points (not stat sig)||N/A|
|Sources: company releases, clinicaltrials.gov.|