BLI-1008 / ABVC BioPharma - LARVOL DELTA

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=70 | Completed | Sponsor: BioLite, Inc. | Suspended ➔ Completed | Trial completion date: Jun 2024 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • 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

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=99 | Suspended | Sponsor: BioLite, Inc. | Recruiting ➔ Suspended

Trial suspension • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

ABVC BioPharma Announces Completion of Subject Treatment for Interim Analysis on ADHD Phase IIb Clinical Study (GlobeNewswire) - P2b | N=99 | NCT05202327 | Sponsor: BioLite, Inc. | "ABVC BioPharma, Inc...announced an update on the Company's eight-week long ADHD Phase II part II clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese medical centers. A total of 94 subjects were screened, out of which 69 enrolled in the study; 60 subjects completed the eight-week study....'Following the successful completion of the eight-week long treatment, we expect to hear a positive result in the interim analysis report and hope to continue the study in the next part by enrolling another thirty patients to complete the Phase II study.'"

P2b data • Attention Deficit Hyperactivity Disorder • CNS Disorders

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: BioLite, Inc. | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

ABVC BioPharma ADHD Phase II Part 2 Clinical Study First Subject Enrolled at UCSF (GlobeNewswire) - "ABVC BioPharma, Inc...announced that the first subject was enrolled at University of California San Francisco (UCSF) Medical Center on June 9, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, Psychiatry UCSF Weill Institute for Neurosciences, joins the five (5) Taiwan sites that have begun patient enrollment for the Company’s ADHD Phase II Part 2 clinical study.... Part II is a randomized, double-blind, placebo-controlled study involving a total of approximately one hundred (100) patients in the United States and Taiwan. A total of fifty-three (53) participants have been enrolled and forty-three (43) have completed the eight-week study thus far."

Enrollment open • Attention Deficit Hyperactivity Disorder • CNS Disorders

"Last Week ABVC Received Taiwan Regulatory Approval for ABV-1505 ADHD Phase II Part 2 Clinical Study Company also filed for mixed shelf offering" (@MerooNepal)

Clinical • P2 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

"$ABVC Central IRB Approved for ABV-1505 Phase II Part II in Taiwan Sites https://t.co/A7YehdANan #clinicaltrial" (@stock_titan)

Clinical

ABVC BioPharma Completes Site Selection for ABV-1505 ADHD Phase II Part 2 Clinical Study (GlobeNewswire) - "ABVC Biopharma, Inc...announced it has completed clinical site selection for its ABV-1505 Attention-Deficit Hyperactivity Disorder (ADHD) Phase II Part 2 study....The Part 2 study of ABV-1505 (ADHD) is a multi-nation multi-site randomized, double-blind, placebo-controlled study involving approximately 100 patients. The study sites selected are the University of California, San Francisco (UCSF) in the USA and five prestigious medical centers in Taiwan, including the National Taiwan University (NTU) Hospital, Cheng Hsin General Hospital, Linkou Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital, and Taipei Veterans General Hospital. In parallel with the Institutional Review Board (IRB) submission at UCSF, a central IRB (cIRB) submission of the protocol and study-related dossiers will be issued by ABVC in Q4, 2021 for all five Taiwan sites. The study is targeted to begin in the first quarter of 2022."

Trial status • Attention Deficit Hyperactivity Disorder • CNS Disorders

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

American BriVision Announces Completed Patient Enrollment in Clinical Trial at UCSF for Treatment of Adult ADHD (GlobeNewswire) - "The company said that ABV-1505, with the active pharmaceutical ingredient PDC-1421, has been successfully evaluated in a recently completed Phase II study conducted at Stanford University and five major medical centers in Taiwan for the treatment of major depressive disorder (MDD)."

Trial completion • CNS Disorders • Depression

American BriVision Conducts Site Monitoring Visit for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) (GlobeNewswire, American BriVision Holding Corporation) - "American BriVision (Holding) Corporation...today announced that a site monitoring visit was conducted on March 10 and March 11, 2020 at the University of California San Francisco (UCSF) Medical Center for ABV-1505 Phase II Part I clinical trial...for Adult Attention-Deficit Hyperactivity Disorder (ADHD)....As of the site monitoring visit, four qualified adult ADHD patients had been enrolled and treated with PDC-1421 Capsules. Among them, two will complete their treatment of PDC-1421 according to the study protocol on April 8 and April 11, 2020 respectively. The overall site monitoring visit went wel...'We are pleased to announce that our Phase II Part I trial of ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) is proceeding at the University of California, San Francisco (UCSF) Medical Center,' said Dr. Howard Doong, Chief Executive Officer of the Company."

Enrollment status • FDA event

American BriVision First Patient Enrolled for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) (GlobeNewswire, American BriVision Holding Corporation) - "American BriVision (Holding) Corporation...today announced the first patient enrollment of ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for adult attention-deficit hyperactivity disorder (ADHD). The new study will be conducted at the University of California San Francisco (UCSF) Medical Center. This trial is an open label, single-center, dose escalation study designed for the enrollment of six adult ADHD patients....A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and assuming successful completion of this Phase II Part I study."

Enrollment status • New P2 trial • Trial status

American BriVision provides corporate update (GlobeNewswire) - "A Phase II Part I clinical trial, under FDA clinical protocol code BLI-1008-001 for adult attention-deficit hyperactivity disorder (ADHD), was initiated at the University of California San Francisco (UCSF)...A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and subject to successful completion of this Phase II Part I study. The Phase II clinical study with ABV-1505 for the treatment of adult ADHD patients is aiming to further expand PDC-1421’s therapeutic indication."

Clinical • New P2 trial • Pipeline update

American BriVision Initiates Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) (GlobeNewswire, American BriVision Holding Corporation) - "American BriVision (Holding) Corporation...today announced the initiation of a new ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for adult attention-deficit hyperactivity disorder (ADHD). PDC-1421, the active pharmaceutical ingredient of ABV-1505 and ABV-1504, has been successfully evaluated in a recently completed Phase II study for major depressive disorder (MDD) conducted at Stanford University and five major medical centers in Taiwan."

Clinical • Clinical data • New trial • Regulatory