FREMONT, CA, June 05, 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 released positive clinical results showing both efficacy and safety for the Company’s ABV-1504 Phase II (Part 2) trial, under the U.S. Food and Drug Administration (FDA) and Taiwan FDA clinical protocol code of BLI-1005-002, in major depressive disorder (“MDD”).
This study was a randomized, double-blind, placebo-controlled, multi-center trial in which 60 adult patients with confirmed moderate-to-severe MDD were treated with PDC-1421 low dose (380 mg), PDC-1421 high dose (2 x 380 mg), or placebo for 6 weeks, three times per day. PDC-1421 is the active pharmaceutical ingredient of ABV-1504.
PDC-1421 high dose (2 x 380 mg) met the prespecified 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 from baseline (i.e., overall treatment effect), as compared to a 9.2-point reduction in the placebo group. These results support further development of PDC-1421 in MDD.
Both the low and high doses of PDC-1421 were safe and well tolerated with no serious adverse events.
“We believe that the positive Phase II results of our lead drug candidate PDC-1421 for MDD supports our approach of using botanical active pharmaceutical ingredients in our drug development,” said Dr. Howard Doong, Chief Executive Officer of American BriVision.
The World Health Organization has reported that more than 300 million people of all ages suffer from MDD, also known as clinical depression, worldwide. In the U.S., MDD affects over 16 million adults, or approximately 7% of the population over age 18, and it is the leading cause of disability in the U.S. for ages 15-44.
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) and then out-licensing the products to international pharmaceutical companies for pivotal Phase III studies and, eventually, generating global sales. The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Forward-looking Statements
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