ABVC BioPharma Inc. (NASDAQ: ABVC) has announced that the Taiwan Central Institution Review Board (CIRB) has approved the start of Phase II Part 2 study of ABV-1505 Attention-Deficit Hyperactivity Disorder treatment at five medical centres in the country.
The study enrolled 100 patients in Taiwan
The Part 2 study is a double-blind, randomized, placebo-controlled trial in Taiwan studying about 100 patients. Part 1 of Phase II ABV-1505 study was conducted at the University of California, San Francisco, from January to July 2020 and accepted by the FDA in October 2020. ABVC is also waiting for approval to conduct part of the study in the UCSF Medical Center. Part 2 of the study is set to begin in the first quarter of 2022 and will be finished by the end of the year.
Part 1 of the trial indicated that the active ingredient in ABV-1505, PDC-1421, was well-tolerated, safe, and effective in six adult patients during treatment and follow-up. The percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline to eight weeks of treatment in the Intention-To-Treat population per-protocol population for the primary endpoints were 83.3% and 80%, respectively. In addition, both high and low doses of PDC-1421 met the primary goals, with 40% of the participants passing the ADHD-RS-IV exam.
ABVC expects IRB approval from UCSF
ABVC BioPharma CEO Howard Doong said, “We are delighted to receive approval of all five Taiwan sites for the ABV-1505 ADHD Phase II Part 2 study protocol from Taiwan’s Central IRB. We expect to receive IRB approval from UCSF later this year and begin the study in both Taiwan and the US in the first quarter of 2022. With a focus on botanical sourcing in drug development, ABVC BioPharma’s clinical trials continue to demonstrate that medicines derived from plants and administered in appropriate doses have significant therapeutic benefits with few – if any – side effects in treating serious medical conditions.”