PDC-1421, the active ingredient of ABV-1505, is being expanded into adult ADHD trials following encouraging Phase II trial results in major depressive disorder (MDD)
First of six patients has been enrolled for Phase II Part I trial of ABV-1505 at the University of California, San Francisco (UCSF) Medical Center
Phase II Part II trial of ABV-1505 is expected to follow Part I and be conducted at UCSF and major medical centers in Taiwan
FREMONT, CA, March 04, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- American BriVision (Holding) Corporation (ABVC) (the “Company”), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced the first patient enrollment of ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for adult attention-deficit hyperactivity disorder (ADHD). The new study will be conducted at the University of California San Francisco (UCSF) Medical Center.
This trial is an open label, single-center, dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive a low-dose treatment (380 mg) thrice daily for 28 days followed by a high-dose treatment (760 mg) thrice daily for another 28 days. PDC-1421, the active pharmaceutical ingredient of ABV-1505, has been successfully evaluated in a recently completed Phase II study for major depressive disorder (MDD) conducted at Stanford University and five major medical centers in Taiwan.
The primary objective of this study is to determine the effective doses and treatment period of PDC-1421 in adult patients with ADHD. The secondary objective is to evaluate the safety of PDC-1421 in patents receiving the drug at various dose levels. A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and assuming successful completion of this Phase II Part I study.
“We are excited to have the first patient enrolled at UCSF Medical Center to kick off the clinical evaluation of PDC-1421 therapeutic benefits in adult ADHD patients,” said Dr. Howard Doong, Chief Executive Officer of the Company.
According to Grand View Research, the global ADHD market size was valued at $16.4 billion in 2018 and is estimated to exhibit a CAGR of 6.4% through 2025, driven by worldwide drug product approvals and launches and increased research and development activities.
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). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
CAUTIONARY STATEMENT CONCERNING FORWARD LOOKING STATEMENTS
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable terms for planned financing and the possibility that we may be unable to complete the up-listing in the currently anticipated timelines or at all, that the possibility of unfavorable results from ongoing and additional clinical trials involving Vitargus and the possibility that we may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that the parties may make a strategic decision to discontinue development of Vitargus, and as a result, Vitargus may never be successfully commercialized. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; our having adequate funding to conduct our clinical trials; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this document and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this document, and other statements made from time to time by us or our representatives that might occur.
Andy An – Chief Financial Officer