FREMONT, CA - (NewMediaWire) - May 04, 2023 - ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced it received a US patent certificate, US 11,554,154 B2, for PDC-1421, for the treatment of Major Depressive Disorder (MDD) on April 25, 2023.
The patent application was submitted to the US Patent and Trademark Office (USPTO) on July 22, 2020, under the title of “Polygala Extract for the Treatment of Major Depressive Disorder.” The invention relates to a method for treating Major Depressive Disorder by orally administering a composition containing a Radix Polygalae (Polygala tenuifoliaWilld.) extract (PDC-1421). PDC-1421 is a drug product of ABV-1504 that can be prepared into a gelatin capsule for oral administration. The composition can be administered chronically over at least 25 days; the daily dose can be administered once per day, twice per day, or three times per day, wherein each dose is 380 - 760 mg of the botanical extraction.
ABV-1504 is a botanical-based Norepinephrine Transporter (NET) inhibitor that has completed Phase II clinical studies, with plans to initiate an End of Phase II (EOP II) meeting with the FDA shortly.
The patent was also submitted for Patent Cooperation Treaty (PCT) and subsequently filed in several countries, including the European Union, China, Japan in 2022.
“This patent grants the right to exclude others from using, offering, or selling Polygala tenuifoliaWilld. extract (PDC-1421), the drug product of ABV-1504, throughout the United States until July 22, 2040,” said Dr. Howard Doong, ABVC Chief Executive Officer. “We believe the patent will be granted in the European Union, China, Japan, and other countries.”
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, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III.
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