Clinical stage biopharmaceutical company American BriVision has reportedly released positive outcomes of its ABV-1504 Phase II clinical trial, under Taiwan FDA clinical protocol code of BLI-1005-002 and the U.S. Food and Drug Administration, for major depressive disorder.

As per trusted sources, the trial was randomized, placebo-controlled, double-blind, and multi-centered, comprising 60 adult patients having moderate-to-severe MDD. Patients reportedly received a PDC-1421 high dose of 2 x 380 mg, PDC-1421 low dose of 380 mg or placebo for 6 weeks, three times a day.

For the record, the drug candidate PDC-1421 is the active therapeutic ingredient of ABV-1504. A high dose of PDC-1421 attained the primary prespecified endpoint by depicting an extremely significant 13.2-point drop in the Montgomery-Åsberg Depression Rating Scale total score through Intention-To-Treat analysis, assessed over the 6-week treatment period from baseline, compared to a 9.2-point drop in the placebo group. These outcomes further support the development of PDC-1421 in MDD, cited sources familiar with the trial.

According to Dr. Howard Doong, CEO of American BriVision, the company believes that the positive Phase II outcomes of its lead drug candidate PDC-1421 favors firm’s approach of utilizing botanical active pharmaceutical components to develop the drug.

Data by the World Health Organization suggests that over 300 million people of all ages are affected by MDD or clinical depression, worldwide. In the United States, more than 16 million adults, or around 7% of the population above the age of 18 suffer from MDD and it is the top cause of disability for ages between 15-44 in the country.

For the record, American BriVision’s aims to utilize its licensed technology to perform proof-of-concept trials via Phase II of the clinical development process at some of the world’s most eminent research institutions such as Stanford University, Cedars-Sinai Medical Center, and the University of California at San Francisco, then generate global sales by out-licensing the products to international pharmaceutical firms for Phase III studies, reported sources.

Source Credit https://www.globenewswire.com/news-release/2019/06/05/1864963/0/en/American-BriVision-Announces-Positive-Phase-II-Part-2-Results-for-ABV-1504-for-Major-Depressive