ABVC BioPharma, Inc. (NASDAQ:ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced it has filed new PCT (Patent Cooperation Treaty) applications in connection with its medicines that treat major depressive disorder (MDD) and Attention-Deficit Hyperactivity Disorder (ADHD). The two PCT applications describe the treatment methods of oral administrating compositions containing Radix Polygalae (Polygala tenuifolia Willd) extract (PDC-1421). PDC-1421 is the active ingredient for both the company's MDD and ADHD drugs.
A recently completed Phase II Part II clinical study for ABVC's MDD medicine was a randomized, double-blind, placebo-controlled, multi-center trial, involving 60 adult patients with confirmed moderate to severe MDD who were treated with PDC-1421 three times a day for six weeks. PDC-1421 met the pre-specified primary endpoint by demonstrating a highly significant 13.2-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score by Intention-To-Treat (ITT) analysis, averaged over the 6-week treatment period (overall treatment effect) from baseline, as compared to 9.2-point reduction of the placebo group. By Per-Protocol (PP) analysis, PDC-1421 showed a dose dependent efficacy toward MDD in which high dose (2 x 380 mg) gave 13.4-point reduction in MADRS total score from baseline and low dose (380 mg) gave 10.4-point reduction as compared to 8.6 in the placebo group. The patients exhibited no severe adverse events.
"We believe that the PCT filings, which provide quick entries to PCT contracting countries, such as China, Japan and European Union, can facilitate the global IP protection of our important MDD and ADHD products," said Dr. Howard Doong, ABVC BioPharma chief executive officer. "The PCT's and subsequent national phase applications, when granted, can extend our product's global market exclusivity to 2040~2041."
Dr. Doong emphasized the importance of ABVC BioPharma's focus on botanical sourcing in drug development. "Our clinical trials continue to demonstrate that medicines derived from plants have significant therapeutic benefits with few - if any - side effects in treating serious medical conditions."