In a Dec. 30 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that BioXcel Therapeutics Inc. (BTAI:NASDAQ) launched its pivotal trial program for BXCL501, an acute treatment for agitation in patients with schizophrenia and bipolar disorder.
Selvaraju explained the program and trial design. This SERENITY (Sublingual dExmedetomidine in agitation associated with schizophRENIa and bipolar disorder sTudY) program of BioXcel will consist of two Phase 3 studies, topline results from which are expected in mid-2020. Randomized, double blinded and placebo controlled, these trials will include up to 750 patients, aged 18 to 75 years.
SERENITY I will evaluate BXCL501 in patients with schizophrenia-associated agitation whereas SERENITY II will assess it in patients with bipolar disorder-associated agitation. Both I and II will consist of three cohorts, each of which will receive either BXCL501 120 micrograms, BXCL501 180 micrograms or a placebo.
The primary endpoint, Selvaraju noted, will be reduction of acute agitation symptoms measured via the change in the PANSS excited component (PEC) from baseline, compared to that with placebo. "We consider the PEC scale a validated endpoint and believe that statistically significant impact on this endpoint ought to constitute appropriate evidence to support regulatory approval and demonstrate clinical meaningfulness," added the analyst.
The key secondary endpoints of both SERENITY studies include delineating the earliest time an effect on agitation is seen, as measured by the change from baseline in the total PEC score.
Finally, Selvaraju commented that "BXCL501 is a rapidly acting agent being developed in a number of acute care indications; accordingly, we believe this program could constitute a near-term value driver." Further, if the SERENITY trials yield positive results, they could support the filing of a new drug application (NDA) for BXCL501 through the 505(b)(2) regulatory route. As such, BioXcel could file that NDA in H2/20.
H.C. Wainwright & Co. has a Buy rating and a 12-month target price of $25 per share on BioXcel, whose stock is now trading at around $13.60 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., BioXcel Therapeutics, Inc., Company Update, December 30, 2019
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of BioXcel Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of November 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioXcel Therapeutics, Inc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from BioXcel Therapeutics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from BioXcel Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in BioXcel Therapeutics, Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.