In a Feb. 5 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that BioXcel Therapeutics Inc.'s (BTAI:NASDAQ) Phase 1 study results of intravenous (IV) dexmedetomidine for opioid withdrawal symptoms were "encouraging."
The proof-of-concept study showed all of the 10 patients who received dexmedetomidine demonstrated "substantial improvement" of their symptoms, as measured on the clinical opioid withdrawal scale (COWS). They showed a drop in their COWS scores after 75 or fewer minutes, some in under 30 minutes. Tolerating the drug well, the participants did not experience any adverse events. The five patients who received the placebo did not report any benefit.
The results were "particularly impressive," highlighted Selvaraju, "given the fact that this group of patients was classified as undergoing mild to moderate withdrawal" and yet, a clear drug benefit among them was delineated.
Selvaraju commented that the indication of opioid withdrawal "should be an attractive opportunity due to the fact that application would be in an acute setting (no more than 14 days of longitudinal dosing), making clinical development a rapid process."
Data from this and previous Phase 1 studies should help BioXcel decide on the optimal dose of BXCL501, its sublingual form of dexmedetomidine being developed for agitation, the analyst noted. In those prior trials, IV dexmedetomidine was administered for not only opioid withdrawal symptoms but also in Alzheimer's disease and schizophrenia patients and in healthy older volunteers.
Regarding BXCL501, the Phase 1 will be a placebo-controlled, dose escalation study in which 60 healthy volunteers will be enrolled and divided among four dosing groups. Those receiving the drug will get only one dose. Pharmacokinetics and safety will be the primary endpoints.
H.C. Wainwright & Co. has a Buy rating and a 12-month price target of $25 per share on BioXcel, whose stock is currently trading at about $9.60 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., BioXcel Therapeutics Inc., Company Update, February 5, 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 January 31, 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.
A research analyst of the firm and/or the research analyst’s household has a financial interest in and own the securities of Bausch Health Companies Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of January 31, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Bausch Health Companies Inc.
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 did not receive compensation from Bausch Health Companies Inc. for investment banking services within twelve months before, but 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 or its affiliates did 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. and Bausch Health Companies 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.