Fremont, CA - (NewMediaWire) - May 23, 2022 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that Dr. Maurizio Fava and Dr. Thomas Laughren have agreed to provide consulting services in connection with clinical studies of its central nervous system medicines designed to alleviate symptoms of Major Depression Disorder (MDD) and Adult Depression Hyperactive Disorder (ADHD). The company’s MDD medicine has successfully completed Phase II clinical studies which were accepted by the U.S. Food & Drug Administration in October 2020. Its ADHD medicine successfully completed Phase II, part 1 and is initiating part 2 at the University of California, San Francisco Medical Center as well as at five clinical study sites in Taiwan.

 

Dr. Fava is Psychiatrist-in-Chief of the Massachusetts General Hospital (MGH), executive director of the Clinical Trials Network and Institute, (MGH), associate dean for clinical and translational research and the Slater Family Professor of Psychiatry at Harvard Medical School. He is a world leader in the field of depression, has edited eight books and authored or co-authored more than 900 original articles published in medical journals with international circulation, articles which have been cited more than 95,000 times in the literature and with an h index of over 150. Dr. Fava obtained his medical degree from the University of Padova School of Medicine and completed residency training in endocrinology at the same university. He then moved to the United States and completed residency training in psychiatry at MGH. He founded and was director of the hospital’s Depression Clinical and Research Program from 1990 until 2014. Under Dr. Fava’s direction, the Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work. In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical trials in psychiatry.


Dr. Thomas Laughren is Director of Regulatory for the MGH Psychiatry Clinical Trials Network and Institute, providing consultations on psychiatric and neurologic drug development. He retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA in December 2012. As Division Director, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. Prior to coming to FDA in September 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and completed residency training in psychiatry at the University of Wisconsin. He has authored and co-authored many papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs and is a frequent speaker at professional meetings on these same topics. Dr. Laughren has received numerous awards for his regulatory accomplishments.


“We are pleased that Doctors Fava and Laughren have agreed to provide their invaluable advice as we move our MDD and ADHD medicines through the clinical study regulatory process,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “Their experience with psychiatric medicine and the regulatory process are unmatched in the United States today.”


About ABVC BioPharma

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, it is 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). For Vitargus®, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe. 


Forward-Looking Statements

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 to 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.


Contact:

ICR, LLC 

Lucy Peng

Phone: +1 646-677-1872

Email: Lucy.Peng@icrinc.com