· Last patient last visit (LPLV) marked the final step toward the completion of ABV-1505 Phase II Part I clinical trial in treatment of adult attention-deficit hyperactivity disorder (ADHD).
· Preliminary Phase II Part I results indicated effective dosage and treatment period of ABV-1505.
· Phase II Part II study is expected to follow after the completion of the clinical study report (CSR) of the Phase II Part I study.
FREMONT, CA, July 28, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — American BriVision (Holding) Corporation (OTCQB: ABVC), a clinical stage biopharmaceutical company focused on supporting novel therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that on July 15, 2020, the last patient last visit (LPLV) marked the final step toward the completion of the ABV-1505 Phase II Part I clinical trial for the treatment of adult ADHD.
This current trial is an open label, single-center and dose escalation study designed for the enrollment of six adult ADHD patients. During the trial, each patient received a low-dose treatment (380 mg) thrice daily for 28 days, followed by a high-dose treatment (760 mg) thrice daily for another 28 days. The primary objective of this study is to determine the effective doses and treatment period of ABV-1505 in adult patients with ADHD. The secondary objective is to evaluate the safety of ABV-1505 in patients receiving the drug at various dose levels.
A final monitoring visit with the clinical team at the University of California San Francisco (UCSF) Medical Center was conducted and completed on July 22, 2020. It is expected that the company will issue a clinical study report (CSR) in Q4 2020. Following issuance of the report, a Phase II Part II study will be conducted at the UCSF Medical Center and at major medical centers in Taiwan.
“We are pleased to report the LPLV of our ABV-1505 Phase II Part I clinical trial for the treatment of adult ADHD,” said Dr. Howard Doong, Chief Executive Officer of American BriVision. “And we are extremely grateful to the investigators at UCSF and to the patients who made the study possible, particularly during this challenging COVID-19 pandemic period. Based on encouraging Phase II trial results thus far with our ABV-1504 to treat major depressive disorder (MDD), we expect ABV-1505 to be equally or even more effective than many of the medications currently available to relieve ADHD sufferers. Additionally, we expect patients to experience mild to moderate, if any, side effects from the ABV-1505.”
Dr. Doong noted that both ABV-1504 and ABV-1505 are derived primarily from the plant-based compound PDC-1421. “We look forward to initiating the Phase II Part II study for adult ADHD later this year or in early 2021.”
According to Grand View Research, the global ADHD market size was valued at $16.4 billion in 2018 and is estimated to exhibit a CAGR of 6.4% through 2025, driven by worldwide drug product approvals and launches supported by increased research and development activities.
About American BriVision
American BriVision is a clinical stage biopharmaceutical company focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Clinical trials are in early stages and there is no guarantee that any specific outcome will be achieved. Past performance is not indicative of future results. Investments may be speculative and illiquid, and there is a risk of loss.
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Andy An – Chief Financial Officer