ABV-1601 / ABVC BioPharma - LARVOL DELTA

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Feb 2027 ➔ Feb 2028 | Trial primary completion date: Feb 2027 ➔ Feb 2028

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Oncology • Psychiatry

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Feb 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

The role of adrenergic neurotransmitter reuptake inhibitors in the ADHD armamentarium. (PubMed, Expert Opin Pharmacother) - "The authors conducted a PubMed literature search using the following key words: 'ADHD' AND 'adrenergic reuptake inhibitors' OR 'nonstimulants' OR 'atomoxetine' OR 'Viloxazine' OR 'Dasotraline' OR 'Centanafadine' OR 'PDC-1421' OR 'Reboxetine' OR 'Edivoxetine' OR 'Bupropion' OR 'Venlafaxine' OR 'Duloxetine.' They reviewed FDA fact sheets of available medications for safety/tolerability studies and reviewed published clinical studies of these medications for treatment of ADHD. Adrenergic neurotransmitter reuptake inhibitors fit the diverse needs of children and adolescents with ADHD with 1) poor tolerability to stimulants (e.g. due to growth suppression, insomnia, rebound irritability, co-morbid depression, anxiety and tic disorders, substance abuse or diversion concerns), 2) cardiac risks, and/or 3) need for extended duration of action. Their differences in receptor..."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • Substance Abuse • Tic Disorders • Tourette Syndrome

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Mar 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

ABVC BioPharma Provides ABV-1601 Update on Phase I Site Initiation Visit Conducted at Cedars-Sinai Medical Center (CSMC) (GlobeNewswire) - "ABVC BioPharma, Inc...announced that the Phase 1 Site Initiation Visit (SIV) of ABV-1601 was successfully conducted at Cedars-Sinai Medical Center (CSMC) in West Hollywood, California on March 31, 2023. The SIV was an organized meeting to discuss Phase I study protocol with the principal investigator, Scott A. Irwin, M.D., Ph.D. and begin training clinical personnel....ABVC expects to initiate the Phase II study of ABV-1601 in the fourth quarter of 2023..."

Trial status • CNS Disorders • Depression • Major Depressive Disorder • Oncology

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Mar 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2; N=12; Not yet recruiting; Sponsor: BioLite, Inc.; Trial completion date: Mar 2022 ➔ Mar 2023; Trial primary completion date: Mar 2022 ➔ Mar 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

ABVC: Company Continues to Advance Lead Assets & Earlier Stage Candidates (Yahoo Finance) - "ABVC's active pipeline, two lead products - ABV-1505 and Vitargus® - are in advanced stages of development, as noted, and also importantly have the potential for multiple programs. For instance, the active ingredient in ABV-1505 (and in ABV-1504 and ABV-1601) is PDC-1421...ABVC is evaluating PDC-1421’s efficacy in treating major depressive disorder (MDD)....ABVC's clinical trial for the treatment of MDD in cancer patients studying ABV-1601 at Cedars-Sinai Medical Center (CSMC) in Los Angeles has been posted on the CSMC website. ABVC hopes to finalize the CSR by year-end 2021. ABVC also expects to form a commercial partnership in the U.S. to collaborate the development of ABV-1504 for the treatment of MDD..."

New P1/2 trial • CNS Disorders • Depression • Major Depressive Disorder

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2; N=12; Not yet recruiting; Sponsor: BioLite, Inc.; Trial completion date: Dec 2022 ➔ Mar 2022; Trial primary completion date: Aug 2022 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Oncology • Psychiatry

American BriVision Issues Shareholder Letter Outlining Achievements of 2020 and Outlook for 2021 (Streetinsider.com) - "ABV-1504, 1505 and 1601: In the first quarter of 2021, we will initiate an ABV-1601 Phase II Part 1 clinical trial for the treatment of major depression disorder in cancer patients at Cedars-Sinai Medical Center in Los Angeles, California. The clinical study report (CSR) should be finalized at the year-end. The CSRs of ABV-1504 Phase II for MDD, ABV-1601 Phase II for MDD for cancer patients...will enable us to have further discussions with major pharmaceutical companies about funding Phase III clinical trials and distribution."

Financing • New P2 trial • CNS Disorders • Depression