BioXcel Therapeutics Inc.
09/10/2025 | Press release | Distributed by Public on 09/10/2025 04:31
Material Event (Form 8-K)
| Item 8.01 | Other Events. |
On September 10, 2025, BioXcel Therapeutics, Inc. (the "Company") announced positive topline exploratory efficacy data from SERENITY At-Home Pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia
The SERENITY At-Home study is a Pivotal Phase 3, double-blind, placebo-controlled, 12-week clinical trial designed to evaluate the safety of BXCL501 (120 mcg dose) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in an at-home setting. The trial also included an exploratory objective of assessing the continued efficacy of BXCL501 in the treatment of episodes of agitation.
SERENITY At-Home Topline Summary
| · | A total of 246 patients randomized |
| · | Data collected on 2,628 agitation episodes in 215 patients over a 12 week period |
| o | Treated 2,437 episodes in 208 patients |
| o | 168 patients (81%) completed the full 12-week trial |
| o | Average of 11.7 agitation episodes recorded per treated patient |
| o | Reported agitation episodes were classified as mild (664), moderate (1,369) or severe (395) |
| · | All patients were able to successfully self-administer the film |
| · | Distribution of enrolled patients was 45% bipolar disorders and 55% schizophrenia |
| · | Protocol allowed for concomitant interventions to self-regulate or manage agitation episodes |
SERENITY AT-Home Topline Exploratory Efficacy Results
The efficacy of IGALMI® has already been established in the institutional setting in the SERENITY I and II trials that led to the approval by FDA (see label). In addition to the primary objective of evaluating the safety of BXCL501, the SERENITY At-Home trial also had an exploratory objective of assessing continued efficacy of BXCL501 with repeat dosing. The trial was not powered for these assessments. The positive results demonstrated continued effects and consistent benefits with repeat dosing of BXCL501, reinforcing the potential of BXCL501 in the outpatient setting.
Effect Across Total Number of Agitation Episodes
Across 2,433 treated episodes in the trial, BXCL501 demonstrated a significant mean reduction in the modified Clinical Global Impression-Severity (mCGI-S) score from baseline compared to placebo at 2 hours (p<.05).
Effect Across Severity of Agitation Episodes
Patients experienced a complete resolution of agitation symptoms measured by mCGI-S at significantly higher rates with BXCL501 compared to placebo across severity of agitation episodes, with an overall resolution of 50% in the BXCL501 arm, compared to 33% on placebo (p <.0001). Severe agitation episodes fully resolved (no agitation) in 61% of episodes in the BXCL501 arm, compared to 18% on placebo (p <.0001). Moderate agitation episodes fully resolved in 43% of cases for patients in the BXCL501 arm, compared to 34% on placebo (p =.0005). Mild agitation episodes fully resolved in 60% of cases for patients in the BXCL501 arm, compared to 40% on placebo (p <.0001). In sum, complete resolution of agitation was significantly higher with BXCL501 compared to placebo regardless of agitation episode severity.
Effect Across Number of Treated Agitation Episodes
The mean reduction in agitation symptoms experienced by patients following administration of BXCL501 was maintained throughout repeated dosing in the trial. There was a mean reduction in mCGI-S score of 1.2 following the first 12 doses and a mean reduction of 1.4 following 13 or more doses of BXCL501. This underscores the potential of BXCL501 to continue to provide benefit across repeated dosing.
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