BioXcel Therapeutics Stock Tumbles: Company Releases Mixed Results From Lower Dose Igalmi Study In Bipolar/Schizophrenia Associated Agitation

Vandana Singh
2 min read
0
In this article:

  • BioXcel Therapeutics Inc (NASDAQ: BTAI) announced results for BXCL501, an orally dissolving film of dexmedetomidine, from Part 1 of Phase 3 SERENITY III trial designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use.

  • Part 1 assessed the efficacy and safety of a 60mcg dose, half of the already-approved 120mcg dose (Igalmi).

  • Also Read: BioXcel Therapeutics Reports Encouraging Phase 1b Results For Innovative Depression Treatment.

  • The results are expected to enable the initiation of Part 2 for at-home use. BXCL501 would represent the first-ever FDA-approved therapy for at-home use in this indication if approved.

  • The company plans to proceed with SERENITY III Part 2 using an adaptive trial design with 60mcg or greater dose, such as 80mcg.

  • Clinically meaningful efficacy results were observed with half (60mcg) of the lowest approved dose of Igalmi.

  • In addition, a greater than 50% PEC response rate was achieved, with a responder rate dose-proportionally consistent with those observed in SERENITY I and II trials.

  • Although the primary efficacy endpoint was not statistically significant at 2 hours (p=0.077), BXCL501 separated from placebo at 4 hours (p=0.049).

  • 52% were PEC responders by 2 hours post-dose (p = 0.019 versus placebo). The proportion responding was greater than with placebo as early as 1 hour (p = 0.035) and remained so through 4 hours.

  • The proportion responding by CGI-I assessment (achieving a score of 1 or 2, 'Very much improved' or 'Much improved', respectively) was greater than with placebo at 2 hours post-dose (p = 0.039).

  • Price Action: BTAI shares are down 27.5% at $18.80 on the last check Thursday.

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article BioXcel Therapeutics Stock Tumbles: Company Releases Mixed Results From Lower Dose Igalmi Study In Bipolar/Schizophrenia Associated Agitation originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement

Recommended Stories