Columbia University-LED TRIAL Expected to Add Fourses to Target Completion
FENTANYL Adulterated or Associated with Xylazine (Faax) Designated An Emerting Threat by the White House Office of National Drug Control Policy1
Company to Seek FDA Feedback on Potential Registry Paths
New Haven, Conn., NOV. 06, 2023 (Globe Newswire) -Bioxcel Therapeutics, Inc. (NASDAQ: BTAI), A BIOPHARMACEUTICALUTIRILILING Artification Artification Intelligen CE to Develop Transformalate Medicines in Neuroscience, TODAY AnNOUNCED An UPDATE on the National Institute onDRUG ABUSE (NIDA) -Funded Trial Evaluating BXCL501 (Sublingual DexMedetomidine) as a POTENTIAL TREATMENT for Opioidelder (OUD).
Bioxcel therapeutics is supporting BXCL501 for An ONGOING 4-RM, 160-Patient trial that is Enrolling Patients. Have Been Predanyl and/OR PRE Dominantly Exposed to FENTANYL Adulterated or Associated with Xylazine (FAAX), Which Has Been Designated An Emerging Threatby the White House Office of National Drug Control Policy1. Nida Has Requested Columbia University, The TRIAL Coordinator, to Add A FourTh Site to TRIA l Completion in 2024. After this time, bioxcel therapeutics planes to see
According to nida, xylazine has been linked to an increasing number of overdose dead, People Exposed to xylazine often Knowingly Or unknowingly used it in composition with other drugs, particularly Illicit feels ,2 RecentlyThe Biden Administration Requested $ 46 Billion in ITS FISCAL 2024 National Drug Control Budget3 To Address The Opioid Epidemic, WHILE OPIOID SETTLEMENTS Between U.S. State and Local GovernAnts and the 14 Major Pharmaceutical Opioid ManuFactures, Distributors, and RETAILERS HAVED BETWEEN $ 51 on and nearly $ 55billion.4
"We have long knowing that the local coerus drives varioid withdrawal Symptoms5 But Lacked Access to a Sublingual formulation of , OF the MOST POTEENT and Selective Alpha 2-Adrence Receptor Available, as a Treatment Option, "Said Dr. SandraComer, Principal Investigator of the trial and Professor of Neurobiology in the Department of Psychiatry at Columbia University. “With BXCL501, we are excited about the potential to treat patients who are physically dependent on illicit and prescription opioidsMumbai Stock Exchange. We believe dexmedetomidine might be particularly helpfulIn Treating withdrawal Symptoms in Patients WHO Are Dependent on Fentanyl and/OR FENTANYL Adultaticd with xylazine. ""
Between June 2020 and January 2021, Columbia University Enrolled Patients in The Company’s Release TRIAL — A Multicenter, Randomize, Double-Blind, PlaceBo-CONTR. Olled, Ascending-Phase Phase 1B/2 TRIAL Designed to Evaluate the Safety, Pharmacokinetics, ToLerability, and EFFICACYof BXCL501 Administerted Twice Daily for Seven Days — In Patients Experiencing Opioid withdrawal Symptoms. In March 2021, Bioxcel Therapeutics Annound Release To PLINE Results. BxCl501 WAS General Well toLerated, with no seeRe or Serious Adverse Events Reported ACross All Drus Evaluated (30 mcg, 60, 60MCG, 90 mcg, 120 mcg, 180 mcg, and 240 mcg). After further post-HOC Analysis, a Peer-Review Article Published in the American Journal of Drug and Alcohol Abuse in January 2023 6 Reported that the 240 MCG BID DOSE (480 mcg per day) WAS WELL ToLerated, DemonStrated Statistics Significant Reduction in Both Clinical Opiate Withdrawal Scale (COWS) And Subjective Opiate DRAWAL Scale (SOS), and Demonstrated a Greater Completion of Treatment Among Enrolled Patients, 87% of WHOM HAD Been Exposed toFENTANYL. In August 2022, The Company Annunced An Nih Nida Grant to Columbia University to Support FURTHER Studies of BxCl501 for the Treatment of Oud.
"While BXCL501 has alream demonStratived Statistical Significance in Patients Exposed to Fentanyl, this Current Study Has A High Patients Exposed to FA Ax and is comport 180 mcg and 240 MCG BID DOSES to Both Placebo and The Standard of Care, LOFEXIDINE, "Said RobertRisinger, M.D., Chief Medical Office, Neuroscience of Bioxcel Therapeutics. Ulation and Represents An Important Potential Option to Help Address the Growing Oud Crisis. "
The BXCL501 OUD TRIAL is supported by the National Institute on Drug Abuse of the National Institutes of Health (NIH) Under Award Number Ug3DA056247.
*In 2017, The U.S. Federal Government Determined that a Public Health Emerge 13er the Public Health Service Act for the opioid crisSTED, and this deters MIINATION WAS Recently Reneding for 90 Days in September 2023, Although Such Public Health Emergency is Independent from Any Public HealthEmergency Determine Under the Federal Food, DRUG, and Cosmetic Act. A section determination under the act has not ben through woulquisite for fda O DeClare that Circumstances Exist Justifying Emergency Use of Drugs to Address the Public Health Emergence,BEFORE FDA is Authorized to issue emergecy use Authorizations for Oud Drugs. The Company May Consider Advocating for Such Determination Under the Federal Food, DRUG AN D COSMETIC ACT, as Well as a Declaration from the GoverNMENT that Drugs Targeting OUD are eligible for the emergecy use authorizationPATH to Market, Though they Are Not CurrenTly Permitted Under the Law to be Authorized Pursuant to This Pathway TODAY.
Government-SUPPPPPPPPPPPPORGATOR-Initiated Trial ProgramS for BXCL501 and Commercialization Opportunitiesbioxcel TheRapeutics Has RETAINED ALL RIGHTS TO THE TO E Commercialization of BXCL501 in All Potential Indications Evaluated in Clinical Trials Support by the U.S. Government. In Addition to Oud As an Indication, BI oxcel therapeutics has ben awardedKey Opportunities for the Development of BXCL501 in Post-Traumatic Stress Disorder and Alcohol Use Disorder. TS With the U.S. Department of Defense Conggressionally Direct Medical Research Program and Nida. Clinical and Regulatory Responsibility Inical Researches andRegulatory Staff AT Columbia University New York State Psychiatric Institute, The Veterans Affairs Connecticut Healthcare System, Yale University l school, RTI International, and nida.
About BXCL501in Indications Other than Those Aproved by the FDA As Igalmi ™, BXCL501 is an invertingal proprietary, ORALLY DISSOLVING Film Formulation of Dexmedetomidine, a selective Alpha-2 Adrenergic Receptor Agonist. Bioxcel Therapeutics BXCL501 Potentially Target Media OF On, andThe Company Has Observation Anti-Agitation Results in Multiple Clinical Studies SEVEROLALOPSYIATRIC DISORDERS. Xcel Therapeutics for the Acute Treatment of Agitation Association with DEMENTIA DUE to Probable Alzheimer’s Disease and for the Acatment of Agitation. Ed with Bipolar I orII DISORDER or SCHIZOPHNINIA in the At-Home Setting. The Safety and Effical of BXCL501 for These Investigational Used Been Established. Been Granted Breakrough Therapy Designation for the Acute Treatment of Agitation Association with DEMENTIA and FAST TRETSIGNATIONof agitation associated with school, bipolar disorders, and dementia.
About Bioxcel Therabutics, Inc. Bioxcel Therabutics, Inc. (NASDAQ: BTAI) is a BioPharMaceutical Utility Intelligence to Develop TO Deer RansFormative Medicines in Neuroscience. The Company’s Drug Re-Innovation Approach Leverages Existing Drugs and/OR Clinically Validated Product CAN Didates Together withBig Data and Propedary Machine Learning Algorithms to Identify New THERAPEUTIC INDICATIONS. For More Information, Please Visit Bioxcerapeutics.com. FORWARD-L OOOKING Statements this Press Release Includes "Forward-LOOOKING Statements" within the meaning of the private securities litigation reform activity of 1995.We Intend Such FORDARD-LOOOKING Statements to Be Covered by the SAFE HARBOR PROVISISISIONS forces-LOOOKING Statements Containe 27a of the Security Act of 19 33, as amnded (The "Securities Act") and Section 21E of the Securities Exchange Act of 1934, ASENDED (The "Exchange Act"). All Statements Contained in this Press Release Other than Statements of Historial Fact Should Forward-LOOOKING TS, Including, Without Limitation, Statements Regarding: Expected Timing of, Trial Design and Data Results FROMClinical trials of bxcl501, The Potential Addressable Market for BXCL501, Potential Regentrational Paths and Potential Advoice Activities Relation TO 01, The Potential for BXCL501 To Treat Opioid withdrawal Symptoms and Potential Benefits of Such Treatment. The words "Anticipate," "Believe," ""Can," "Continue," "Could," "Designed," "Estimate," "EXPECT," "Forecast," "GOAL," "", "May," "" Possible, "Possible," Possible, "Possible"" POTENTIAL, "Predict," Project, "" Should, "" Target, "" WILL, "" Would "and Similar Expressions are intended to identify-loging statements, this," GH Not AllWard-LOOOKING Statenes Use TheseWords or ExpressionsVaranasi Investment. In Addition, Any Statements or Information that Refer to Expectations, Beliefs, Plans, Projects, Objectives, Performance or Other Characterizations of Future Events or Circumstances, Including Any Underlying Assumptions, are forward-lookings. Based upon the Company’s Current Expectations and Various Assumptions. The Company Believes there is a reASONable Basis for ITS Expectations and BeliefsBut they are inserted. The Company May Not Realize its excectations, and its beliefs may not provide. Those Described Or Implied by Such FORWARD-LOOOKING Statents as a Result of Various Important Factors, Including, Without Limitation, Its Limited Operating History; Risks Association with The StrateGic Repriority; Its Limited Experience in Drug Discovery and Drug Development; Its DEP Endnce on the Success and Commercialization of Igalmi ™, BXCL501, BXCL502, BXCL701 and BXCL702 and Other Product Candidates; ITS Lack of ExperienceIn Marketing and Selling Drug Products; The Risk that Igalmi or The Company’s Product Candidates May Not Be Accepted by Physicians or The Medical Community General; UNDESIRABLE SIDE EFFECTS CAUSED by the Company’s Product Candidates; Its Exposure to Patent Infringement Lawsuits;Parties; Its Ability to Comply with the Extensive Regulations Applicable to It; Its Ability to Commercialize its Product Candidates; Factors Discussed Under The Caption "Risk Factors" in ITS Quarterly Report on Form 10-Q for the Quarterly Period Ended June30, 2023, Which are accessible on the sec’s website at theSe and Other Important Factors CAUSE Actual Results to Differ Materials The Forward-looking statements made in this ance.The date of this present release. While The Company May Elect to Update Such FORWARD-LOOOKINTS at some Point in the Future, Except As Required by Law, It disvlaims any object to do so, even if subsequent events cause our views to change. These forward-loging statements should not be relone Ing the Company ’s Views as of Any Date Subsequent to the Date of This Press Release.
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References
Whitehouse.gov. Biden-Harris Administration Designates Fentanyl Combined with Xylazine as an arterging Threat to the UNITED States. ESSED NOVEMBER 1, 2023. Research Topics. AccessEd November 2, 2023. National Drug Control Budget FY2024 Funding HighlightsMarch 2023. AccessEd November 1, 2023. Global Settlement Tracker. Accessiced November 1, 2023. K 1991. OG Brain Res. 1991; 88: 207-16. Doi: 10.1016/S0079-6123(08) 63810-8. PMID: 1839935.JONES JD, Rajachandran L, YOCCA F, Risinger R, de vivo m, Sabados J, Levin FR, Comer Sd. Sublingual dev -Detomidine (BXCL501) UCES OPIID withdrawal Symptoms: Findings from a Multi-site, phase 1b/2, randomized, double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2023 Jan 2;49(1):109-122Hyderabad Stocks. doi: 10.1080/00952990.2022.2144743. Epub 2023 Jan 11. PMID: 36630319.
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