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American BriVision Announces Issuance of a Full Clinical Study Report (CSR) for ABV-1504 for Major Depressive Disorder Phase II Study
PDC-1421 high-dose data meets primary endpoint on MADRS scale in ITT clinical trial population PDC-1421 low-dose and PDC-1421 high-dose each proved safe,
About this update from Abvc Biopharma, Inc.
[{"type":"text","content":"\n PDC-1421 high-dose data meets primary endpoint on MADRS scale in ITT clinical trial population PDC-1421 low-dose and PDC-1421 high-dose each proved safe, were well-tolerated, and had no serious adverse events associated with them in Phase II clinical trial Company is planning for end-of-Phase II meetings with regulatory authorities to discuss path forward for Phase III pivotal trials FREMONT, CA, Nov. 14, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- American BriVision (Holding) Corporation (OTCQB: ABVC) (the “Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today issued a full clinical study report (CSR), under the U.S. Food and Drug Administration (FDA) and Taiwan FDA (TFDA) clinical protocol code of BLI-1005-002, for ABV-1504 major depressive disorder (MDD) Phase II study. This study consisted of: Part I - an open label, dose escalation study conducted in 12 adult patients for 4 weeks across multiple centers with PDC-1421 low-dose (380 mg) and PDC-1421 high-dose (2 x 380 mg), three times per day Part II - a double-blinded and placebo-controlled trial conducted in parallel groups across 60 adult patients for 6 weeks in multiple centers and randomized (1:1:1) between PDC-1421 low-dose (380 mg), PDC-1421 high-dose (2 x 380 mg), and placebo, three times per day The study was conducted by Stanford University and five major medical centers in Taiwan. PDC-1421 is the active pharmaceutical ingredient of ABV-1504. The clinical study report (CSR) provided the following key study results: PDC-1421 high-dose (2 x 380 mg) met the prespecified primary objective by demonstrating a highly significant 13.2-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in Intention-To-Treat (ITT) population, averaged over the 6-week treatment period from baseline (i.e., overall treatment effect), as compared to a 9.2-point reduction in the placebo group. In the per protocol population, the high-dose cohort had a 13.4-point reduction in MADRS as compared to an 8.6-point reduction in the placebo group. In the ITT population, a greater reduction in net change in HAM-D-17 (Hamilton Depression Rating Scale-17) at week 6 was observed in the high-dose group (-10.95) compared to placebo group (-8.70). A significant group difference in net chan...