NEW HAVEN, Conn., March 15, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BioXcel” or the “Firm”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical firm using synthetic intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, right this moment introduced that BXCL501, the Firm’s investigational, proprietary, orally dissolving skinny movie formulation of dexmedetomidine (“Dex”), has been granted Breakthrough Remedy designation from the U.S. Meals and Drug Administration (“FDA”) for the acute therapy of agitation related to dementia. The Breakthrough Remedy designation is meant to expedite the event and evaluate of sure product candidates designed to deal with critical or life-threatening illnesses or circumstances, and the designation contains elevated interplay and steering from the FDA.
“Managing dementia associated agitation, particularly in aged sufferers, represents a big problem for physicians and caregivers, as there are presently no FDA-approved therapies and off-label medication include black field warnings,” acknowledged Vimal Mehta, Chief Govt Officer of BioXcel. “The FDA’s choice to grant Breakthrough Remedy designation additional underscores the numerous unmet want for a brand new therapy for this underserved affected person inhabitants, in addition to highlights BXCL501’s potential in turning into the primary therapeutic choice, if accepted, to handle this debilitating medical situation. We look ahead to working intently with the FDA to advance BXCL501 right into a pivotal dementia program, in hopes of shortly bringing this remedy to the thousands and thousands of sufferers throughout therapy settings that lack various choices.”
The Breakthrough Remedy designation for BXCL501 was supported by the constructive topline knowledge from the Part 1b/2 TRANQUILITY examine for the acute therapy of agitation related to dementia, together with Alzheimer’s illness. BXCL501 demonstrated statistically vital reductions in agitation measures at 2 hours post-dose with each the 30 and 60 mcg doses as measured by a number of scales. The dose dependent response noticed has the potential to assist the Firm’s plans to judge BXCL501 to be used throughout the complete vary of dementia care settings.
About FDA Breakthrough Remedy Designation
Breakthrough Remedy designation is an FDA program supposed to expedite the event and regulatory evaluate of investigational therapies which are designed to handle critical or life-threatening circumstances. The factors for Breakthrough Remedy designation requires preliminary medical proof that signifies that the candidate might display substantial enchancment over current therapies on a number of clinically vital endpoints. This designation supplies the Firm with extra intensive FDA steering on an environment friendly drug improvement program, and eligibility for different actions to expedite the FDA evaluate, resembling a rolling evaluate of a New Drug Software (“NDA”), the place the FDA might evaluate sections of the NDA earlier than the entire utility is submitted. An NDA for a product candidate receiving breakthrough designation might also be eligible for precedence evaluate if the related standards are met. Breakthrough Remedy designation doesn’t change the requirements for approval. For extra info, please go to the FDA web site at www.fda.gov.
About Dementia Associated Agitation
Dementia is a neurocognitive situation attributable to injury to mind cells that results in a decline in cognitive talents and impartial operate. It impacts roughly 6 million people in the USA, with Alzheimer’s illness accounting for as much as 80% of those instances. Throughout the course of the illness, sufferers with dementia typically undergo from psychological and behavioral signs, resembling agitation, which has been reported in as much as 70% of sufferers. Agitation related to dementia can negatively have an effect on each the affected person and caregiver’s high quality of life. Caregiver burden can contribute considerably to burnout, which can lead to untimely institutionalization of the affected person. Treating agitation related to dementia has been a problem for suppliers as there are presently no FDA-approved therapies for the therapy of dementia-related agitation, and off-label therapies have black field warnings related to their use.
BXCL501 is an investigational, proprietary, orally dissolving skinny movie formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the therapy of agitation and opioid withdrawal signs. BioXcel believes that BXCL501 probably targets a causal agitation mechanism, and the Firm has noticed anti-agitation ends in a number of medical research throughout a number of neuropsychiatric problems. BXCL501 has been granted Quick Monitor Designation by the U.S. Meals and Drug Administration for the acute therapy of agitation in sufferers with schizophrenia, bipolar problems, and dementia. BXCL501 has been studied in two Part 3 trials (SERENITY I and II) for the acute therapy of schizophrenia associated agitation and bipolar dysfunction associated agitation, respectively, and in a Part 1b/2 trial (TRANQUILITY) for the acute therapy of dementia associated agitation. This product candidate can be presently being evaluated in a Part 1b/2 trial (RELEASE) for the therapy of opioid withdrawal signs and in a Part 2 trial (PLACIDITY) for the therapy of delirium associated agitation.
BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical firm using synthetic intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’s drug re-innovation method leverages current accepted medication and/or clinically validated product candidates along with massive knowledge and proprietary machine studying algorithms to establish new therapeutic indices. BioXcel’s two most superior medical improvement applications are BXCL501, an investigational, proprietary, orally dissolving skinny movie formulation of dexmedetomidine for the therapy of agitation and opioid withdrawal signs, and BXCL701, an investigational, orally administered, systemic innate immunity activator in improvement for the therapy of aggressive types of prostate most cancers and superior stable tumors which are refractory or therapy naïve to checkpoint inhibitors. For extra info, please go to www.bioxceltherapeutics.com.
This press launch contains “forward-looking statements” throughout the which means of the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements on this press launch embody however are usually not restricted to the potential for BXCL501 to deal with dementia-related agitation and the timing of the deliberate pivotal Part 3 trial of BXCL501 in dementia-related agitation. When used herein, phrases together with “anticipate,” “being,” “will,” “plan,” “might,” “proceed,” and comparable expressions are supposed to establish forward-looking statements. As well as, any statements or info that confer with expectations, beliefs, plans, projections, goals, efficiency, or different characterizations of future occasions or circumstances, together with any underlying assumptions, are forward-looking. All forward-looking statements are based mostly upon BioXcel’s present expectations and varied assumptions. BioXcel believes there’s a cheap foundation for its expectations and beliefs, however they’re inherently unsure.
BioXcel might not notice its expectations, and its beliefs might not show right. Precise outcomes might differ materially from these described or implied by such forward-looking statements on account of varied essential elements, together with, with out limitation, its restricted working historical past; its incurrence of great losses; its want for substantial extra funding and skill to lift capital when wanted; its restricted expertise in drug discovery and drug improvement; its dependence on the success and commercialization of BXCL501 and BXCL701 and different product candidates; the failure of preliminary knowledge from its medical research to foretell remaining examine outcomes; failure of its early medical research or preclinical research to foretell future medical research; its potential to obtain regulatory approval for its product candidates; its potential to enroll sufferers in its medical trials; undesirable unwanted effects attributable to BioXcel’s product candidates; its method to the invention and improvement of product candidates based mostly on EvolverAI is novel and unproven; its publicity to patent infringement lawsuits; its potential to adjust to the intensive rules relevant to it; impacts from the COVID-19 pandemic; its potential to commercialize its product candidates; and the opposite essential elements mentioned underneath the caption “Threat Components” in its Annual Report on Type 10-Okay for the 12 months ended December 31, 2020, as such elements could also be up to date once in a while in its different filings with the SEC, that are accessible on the SEC’s web site at www.sec.gov and the Buyers part of our web site at www.bioxceltherapeutics.com.
These and different essential elements might trigger precise outcomes to vary materially from these indicated by the forward-looking statements made on this press launch. Any such forward-looking statements signify administration’s estimates as of the date of this press launch. Whereas BioXcel might elect to replace such forward-looking statements in some unspecified time in the future sooner or later, besides as required by regulation, it disclaims any obligation to take action, even when subsequent occasions trigger our views to vary. These forward-looking statements shouldn’t be relied upon as representing BioXcel’s views as of any date subsequent to the date of this press launch.
BioXcel Therapeutics, Inc.
BioXcel Therapeutics, VP of Funding Relations