Fremont, CA - (NewMediaWire) - February 28, 2023 - Fremont, CA - (NewMediaWire) - February 28, 2023 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today provided an update to drug and medical device developments expected in 2023.
Major Depressive Disorder:
ABVC’s MDD medicine, ABV-1504, has successfully completed Phase II at the Stanford University Medical Center and five major medical centers in Taiwan. Later this year, with the help of Dr. Maurizio Fava and Dr. Thomas Laughren, the company expects to conclude discussions with the US FDA on acceptable protocols for Phase III trials for MDD, allowing ABVC to seek potential distribution partners active in manufacturing and distributing Central Nervous System (CNS) medicines.
Dr. Fava is Psychiatrist-in-Chief of the Massachusetts General Hospital (MGH), executive director of the Clinical Trials Network and Institute, (CTNI), 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. Dr. 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 approvals before U.S. commercialization.
The company’s ADHD medicine ABV-1505, is currently in Phase II, part 2, clinical trials at five prestigious medical centers in Taiwan. In addition, in the next several months the part 2 study will begin at the University of California, San Francisco (UCSF) Medical Center. This study is expected to eventually enroll approximately 100 patients in Taiwan and the United States.
Since results of the first subject treated in Taiwan were reported on May 10, 2022, 42 subjects have now been enrolled in the study from a total of 64 subjects screened. 36 of the enrolled participants have already completed the 8-week treatment in accordance with the study design.
Cancer Patient Depression:
A Phase I study of ABV-1601 for treating depression in cancer patients is expected to begin in the first Quarter of 2023 at the Cedars-Sinai Medical Center (CSMC, West Hollywood CA). The Phase I study is open label and will be conducted with 12 cancer patients with moderate to severe depressive symptoms. The main objective of the study is to evaluate the safety of PDC-1421, the primary active ingredient in ABV-1601 in cancer patients. The Phase II study will determine the most effective dosages using a randomized, double-blind, non-inferiority protocol of PDC-1421 versus Wellbutrin XL. ABVC expects to initiate the Phase II study in the fourth quarter of 2023 and then compare the results to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression.
ABVC has initiated a Phase II trial for ABV-1703 for pancreatic cancer at the Cedars Sinai Medical Center utilizing an herbal active ingredient that showed significant promise during Phase I testing conducted in Japan and at the Memorial Sloan Kettering Cancer Center.
While the company’s additional oncology medicines have yet to be determined, ABVC anticipates clinical studies for ABV-1519 for non-small cell lung cancer and ABV-1501 for triple negative breast cancer will be initiated in Q3 2023. The clinical study for ABV-1702 for myelodysplastic syndrome is expected to start in Q4 of 2023. In addition, ABVC intends to submit ABV-1703’s Phase II clinical trial IND to the Taiwan FDA after commencing clinical trials in the United States.
Vitargus is the first biodegradable vitreous substitute to facilitate retina reattachment surgery. The company expects to complete the Phase II trial of Vitargus in Thailand, Australia and Taiwan by the end of 2023 which may lead to distribution agreements in Asia by the end of 2023. ABVC expects the study to further demonstrate that Vitargus has properties that eliminate the need for post-surgery patient face-down positioning and can provide greater patient comfort and visual acuity during the surgical recovery period.
“We were pleased to have completed a financing last week that will allow us to continue to make progress toward meeting our development milestones for 2023,” said Dr. Howard Doong, Chief Executive Officer of the Company; “The $3.175 million convertible note structure was attractive to us since the note conversion price and the associated warrant exercise price were both fixed at $1.05 with adjustments subject to the usual anti-dilution provisions and subsequent equity raises.”
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.
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.
Leeds Chow, CFO