ABVC BioPharma conducts Phase 1 SIV of ABV-1601 at CSMC

ABVC BioPharma announced that the Phase 1 Site Initiation Visit of ABV-1601 was successfully conducted at Cedars-Sinai Medical Center in West Hollywood, California on March 31, 2023. The SIV was an organized meeting to discuss Phase I study protocol with the principal investigator, Scott A. Irwin, M.D., Ph.D. and begin training clinical personnel. ABV-1601, the Phase I open-label study will be conducted with 12 cancer patients with moderate to severe depressive symptoms. The main objective of the study is to evaluate the safety of PDC-1421, the primary active ingredient in ABV-1601, in cancer patients. ABVC expects to initiate the Phase II study of ABV-1601 in the fourth quarter of 2023 and then compare the results to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression. The Phase II study is to determine the most effective dosages using a randomized, double-blind, non-inferiority trial protocol of PDC-1421 vs. Wellbutrin XL. The Company’s previous clinical study of PDC-1421, the primary active ingredient in ABV-1504 as well, included a Phase II study of ABV-1504 for the treatment of patients with major depressive disorder. The study demonstrated a clinically meaningful 13.2-point reduction in Montgomery-Asberg Depression Rating Scale in the Intention-To-Treat high-dose group, compared to a 9.2-point reduction in the placebo group. The study also showed the drug products, both high and low doses, were safe and well tolerated with no serious adverse event over the 6-week treatment period.