● Patient enrollment has been completed for a Phase II Part I clinical trial at the University of California, San Francisco (UCSF) Medical Center
● Primary objective of Phase II Part I clinical trial is to determine the effective dosage of ABV-1505 in treatment of adult attention-deficit hyperactivity disorder (ADHD)
● Recently completed Phase II study at Stanford and other medical centers showed encouraging results with ABV-1505 for treating major depressive disorder (MDD)
Fremont, CA - (NewMediaWire) - June 15, 2020 - American BriVision (Holding) Corporation (OTCQB: ABVC) (the “Company”), a clinical stage biopharmaceutical company focused on supporting novel therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced the completion of patient enrollment of ABV-1505 Phase II Part I clinical trial for the treatment of adult attention-deficit hyperactivity disorder (ADHD). The new study will be conducted at the University of California San Francisco (UCSF) Medical Center.
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).
This current trial is an open label, single-center, dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive 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 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.
“We are pleased that UCSF was able to complete the enrollment of the first six patients during this COVID-19 pandemic period,” said Dr. Howard Doong, Chief Executive Officer of American BriVision. “And we are optimistic that this Phase II Part I clinical trial will indicate therapeutic benefits and the promise of ABV-1505 for adults suffering from ADHD.”
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 and 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, the 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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