PDC-1421, the active ingredient of ABV-1505, is being expanded into Adult ADHD trials following encouraging Phase II trial results in major depressive disorder (MDD)
A site monitoring visit for the on-going Phase II Part I trial of ABV-1505 for the treatment of Adult ADHD was conducted at the University of California, San Francisco (UCSF) Medical Center on March 10 and 11, 2020
Phase II Part II trial of ABV-1505 is expected to follow Part I and be conducted at UCSF and major medical centers in Taiwan
FREMONT, CA, April 06, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – American BriVision (Holding) Corporation (ABVC) (the “Company”), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS and ophthalmology, 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, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for Adult Attention-Deficit Hyperactivity Disorder (ADHD).
This trial is an open label, single-center and dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive a low-dose treatment (380 mg) of PDC-1421 Capsules three times daily for 28 days followed by a high-dose treatment (760 mg) three times daily for another 28 days.
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 well with several minor errors cited and corrected subsequently.
The primary objective of this study is to determine the effective doses and treatment period of PDC-1421 Capsules in adult patients with ADHD. The secondary objective is to evaluate the conditions of the 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, assuming successful completion of this Phase II Part I study.
“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.
According to Grand View Research, the global ADHD market size was valued at $16.4 billion in 2018 and is estimated to exhibit a compound annual growth rate 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, 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