Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — Corporate Update (July 2019)
21 slides from Bioxcel Therapeutics's corporate update, Jul 22, 2019
Slide 1: Forward-Looking Statements
Forward-Looking Statements This presentation includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this presentation include, but are not limited to, statements that relate to the advancement and development of
Slide 2: Agenda
Agenda BXCL501 Phase 1b Trial Results Overview and Summary Vimal Mehta, Ph.D., CEO & Founder BXCL501 Phase 1b Trial Design and Results Rob Risinger, M.D., VP, Clinical Development Q&A BioXcel Therapeutics Team Corporate Outlook & Closing Remarks Vimal Mehta, Ph.D., CEO & Founder BioXcel Therapeutics
Slide 3: Overview and Summary
Overview and Summary Vimal Mehta, Ph.D., CEO & Founder
Slide 4: Trial Summary of Results
BXCL501 Phase 1b Trial Summary of Results BXCL501: a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist (a novel mechanism of action). Clinically meaningful, rapid and durable reductions in PEC score in acute treatment of agitation in
Slide 5: About Agitation
About Agitation Overview Common and costly phenomenon associated with number of psychiatric conditions - 8.3 million suffer from agitation each year in the US - $40 billion per year health care burden Consensus guidelines recommend non-coercive management strategies to protect therapeutic alliance b
Slide 6: Large Market Potential: Anticipated Timeline
BXCL501: Large Market Potential Anticipated Timeline: First NDA submission in 2H 2020 1H 2020 INDICATION 1H 2019 2H 2019 2H 2020 2021 2022 Trial Initiation Clinical Plan Under Development Clinical Plan Under Development Commercial Launch Phase 3: Schizophrenia & Bipolar Disorder Schizophrenia/ Bipol
Slide 7: Trial Design and Results
BXCL501 Phase 1b Trial Design and Results Rob Risinger, M.D., VP, Clinical Development
Slide 8: Current Treatments are Suboptimal
Current Treatments are Suboptimal: Dementia: Antipsychotic drugs (black-box warning) for elderly Psychiatric: Invasive with severe side effects BXCL501 Sublingual Thin Film Dexmedetomidine (Dex) for Acute Treatment of Agitation Fast Track Designation Non-invasive Calmness without sedation Easy to ad
Slide 9: Clinical Trial Design
BXCL501 Phase 1b Trial Clinical Trial Design Phase 1b, randomized, double-blind, placebo-controlled, multi-center, U.S. trial N=135 adult patients with confirmed diagnosis of schizophrenia 6 hour treatment period - Single dose* Dose groups (2:1 randomization) - BXCL501 (20, 60, 80, 120, and 180 mcg)
Slide 10: Clinical Trial Design
BXCL501 Phase 1b Trial Clinical Trial Design BXCL501 (20, 60, 80, 120, 180 mcg) Assessing Agitation Episodes in Schizophrenia Placebo Agitated Schizophrenia Patients Screening Period Primary Endpoint: Change from baseline in PEC score (PANSS-Excitatory Component) Initiated May 2019 Completed July 20
Slide 11: Trial Demographics and Baseline Characteristics
BXCL501 Phase 1b Trial Demographics and Baseline Characteristics Mean age (years): 48.4 for placebo group, 47.2 for BXCL501 group - 89 males:46 females Mean PEC score at baseline: 18.1 (range 14 – 25) for placebo group, 17.8 (range 14 – 26) for BXCL501 group Subjects were on a range of typically pre
Slide 12: Primary Endpoint: Change in PEC Score from Baseline
BXCL501 Phase 1b Primary Endpoint: Change in PEC Score from Baseline % Responders (Reduction in PEC of > 40%) Mean Change in PEC Score from Baseline P-Value Placebo N=36 28% -4.5 BXCL501 (180 mcg) N=18 89% -10.8 < 0.0001 BXCL501 (120 mcg) N=18 67% -9.2 0.0003 BXCL501 (80 mcg) N=18 56% -7.1 0.0152 BX
Slide 13: Secondary Evaluation: Change in ACES from Baseline
BXCL501 Phase 1b Secondary Evaluation: Change in ACES from Baseline Mean Change in ACES Score From Baseline P-Value Placebo N=36 1.20 BXCL501 (180 mcg) N=18 3.94 < 0.0001 BXCL501 (120 mcg) N=18 3.11 0.0005 BXCL501 (80 mcg) N=18 2.33 0.0156 BXCL501 (60 mcg) N=18 2.11 0.0750 *The lowest dose tested, 2
Slide 14: Trial Safety
BXCL501 Phase 1b Trial Safety BXCL501 was well-tolerated with no serious or severe adverse events across the entire dose range. The most common treatment-related adverse events were mild somnolence and dry mouth. A maximum tolerated dose was not reached. All subjects (100%) were able to self-adminis
Slide 15: Trial Summary
BXCL501 Phase 1b Trial Summary Statistically significant improvement in PEC score in the 80, 120, and 180 mcg dose groups for BXCL501 in patients with schizophrenia. Calming effect was durable lasting at least 6 hours as evidenced by separation from placebo for 80, 120 and 180 mcg dose groups. Well-
Slide 16: Pivotal Trial Expected Clinical Trial Design
BXCL501 Phase 3 Pivotal Trial Expected Clinical Trial Design BXCL501 (Two doses) Assessing Agitation Episodes in Schizophrenia and Bipolar Disorder Placebo Trial 1: Agitated Schizophrenia Patients Screening Period Primary Endpoint: Change from baseline in PEC score (PANSS-Excitatory Component) Expec
Slide 17: Key Targeted Milestones for Value Creation
Key Targeted Milestones for Value Creation On Track For First NDA Submission In 2H 2020 BXCL501 Anticipated Timeline Schizophrenia / Bipolar Disorder Phase 1b Trial Initiated (May 2019) Phase 3 Pivotal Trial Initiation First NDA Submission Phase 1b Data Readout (July 22, 2019) Phase 3 Data Readout D
Slide 18: Large Market Potential: Anticipated Timeline
BXCL501: Large Market Potential Anticipated Timeline: First NDA Submission in 2H 2020 1H 2020 INDICATION 1H 2019 2H 2019 2H 2020 2021 2022 Trial Initiation Clinical Plan Under Development Clinical Plan Under Development Commercial Launch Phase 3: Schizophrenia & Bipolar Disorder Schizophrenia/ Bipol
Slide 19: Corporate Outlook And Closing Remarks
Corporate Outlook And Closing Remarks Dr. Vimal Mehta, CEO & Founder
Slide 20: Dr. Vimal Mehta, CEO BioXcel Therapeutics, New Haven, CT 11 vmehta@bioxceltherapeutics.com
Dr. Vimal Mehta, CEO BioXcel Therapeutics, New Haven, CT 06511 vmehta@bioxceltherapeutics.com
Slide 21: BioXcel Therapeutics
ee | bioxcel therapeutics Dr. Vimal Mehta, CEO BioXcel Therapeutics, New Haven, CT 06511. vmehta@bioxceltherapeutics.com