On August 6, 2024 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the second quarter of 2024 (Press release, BioXcel Therapeutics, AUG 6, 2024, View Source [SID1234645410]).
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"We are on track with our business priorities as we focus on bringing BXCL501 to the greatest number of patients in need," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are pleased with the progress with our SERENITY and TRANQUILITY programs and our focused market-access strategy for IGALMI. Our confidence in our lead neuroscience asset is underpinned by its broad therapeutic potential across multiple neuropsychiatric conditions and its growing intellectual property portfolio."
Late-Stage Clinical Programs
· SERENITY At-Home* Pivotal Phase 3 Trial: designed to evaluate the safety of a 120 mcg dose of BXCL501 in the at-home setting for agitation associated with bipolar disorders or schizophrenia.
o Recently received feedback on protocol from U.S. Food and Drug Administration (FDA).
· TRANQUILITY In-Care Pivotal Phase 3 Trial: designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia (AAD).
o Protocol being finalized for planned submission to FDA.
IGALMI (dexmedetomidine) Sublingual film
Post-marketing Requirement (PMR) Study
· Reported positive topline results from PMR study evaluating PRN (as-needed) treatment of IGALMI for agitation associated with bipolar disorders or schizophrenia.
o Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose).
o Although this PMR study was not statistically powered to evaluate repeat dose efficacy, a reduction in agitation was observed for each episode occurring during the seven-day study period, and no serious adverse events were reported following treatment.
Commercialization
· IGALMI net revenue grew 90% in Q2 2024 over Q1 2024 driven by focused market-access strategy and increased contracting with psychiatric care clinics and behavioral health facilities using a small commercial team.
Patent Portfolio
The Company continues to strengthen its intellectual property portfolio for IGALMI.
· Recently received a U.S. Patent and Trademark Office (USPTO) Notice of Allowance for U.S. Patent Application No. 18/526,686 for IGALMI. Once issued by the USPTO, the patent is expected to have an expiration date of January 12, 2043, and will be submitted for listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book").
· This is expected to be the 11th listed U.S. patent for IGALMI in the Orange Book.