FREMONT, CA, June 05, 2019 — 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.
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Howard Doong: [email protected] ; Andy An: [email protected]