ABVC - ABVC BioPharma Announces New PCT Filings for MDD and ADHD Treatments
Fremont, CA - (NewMediaWire) - September 01, 2021 - ABVC Biopharma, Inc. (NASDAQ:ABVC), a clinical stage biopharmaceutical company developing therapeuticsolutions in oncology/hematology, CNS, and ophthalmology, today announced ithas filed new PCT (Patent Cooperation Treaty) applications in connection withits medicines that treat major depressive disorder (MDD) and Attention-DeficitHyperactivity Disorder (ADHD). The two PCT applications describe the treatment methodsof oral administrating compositions containing Radix Polygalae (Polygalatenuifolia Willd) extract (PDC-1421). PDC-1421 is the active ingredient forboth the company’s MDD and ADHD drugs.
A recently completed Phase II Part II clinical study for ABVC’sMDD medicine was a randomized, double-blind, placebo-controlled, multi-centertrial, involving 60 adult patients with confirmed moderate to severe MDD who weretreated with PDC-1421 three times a day for six weeks. PDC-1421 met thepre-specified primary endpoint by demonstrating a highly significant 13.2-pointreduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scoreby Intention-To-Treat (ITT) analysis, averaged over the 6-week treatment period(overall treatment effect) from baseline, as compared to 9.2-point reduction ofthe placebo group. By Per-Protocol (PP) analysis, PDC-1421 showed a dosedependent efficacy toward MDD in which high dose (2 x 380 mg) gave 13.4-pointreduction in MADRS total score from baseline and low dose (380 mg) gave10.4-point reduction as compared to 8.6 in the placebo group. The patientsexhibited no severe adverse events.
“We believe that thePCT filings, which provide quick entries to PCT contracting countries, such asChina, Japan and European Union, can facilitate the global IP protection of ourimportant MDD and ADHD products," said Dr. Howard Doong, ABVC BioPharmachief executive officer. “The PCT’s and subsequent national phase applications,when granted, can extend our product’s global market exclusivity to2040~2041."
Dr. Doong emphasized the importance of ABVC BioPharma’sfocus on botanical sourcing in drug development. “Our clinical trials continueto demonstrate that medicines derived from plants have significant therapeuticbenefits with few - if any - side effects in treating serious medicalconditions.”
AboutABVC BioPharma
ABVC BioPharma is aclinical-stage biopharmaceutical company with an active pipeline of six drugsand one medical device (ABV-1701/Vitargus®) under development. For its drug products, itis focused on utilizing its licensed technology to conduct proof-of-concept trialsthrough Phase II of the clinical development process at world-famous researchinstitutions (such as Stanford University, University of California at SanFrancisco, and Cedars-Sinai Medical Center). For Vitargus®, the company intends to conduct the clinicaltrials through Phase III at various locations throughout the globe.
Forward-LookingStatements
Clinical trials are in earlystages, and there is no guarantee that any specific outcome will be achieved.This press release contains “forward-looking statements.” Such statements maybe preceded by the words “intends,” “may,” “will,” “plans,” “expects,”“anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,”“hopes,” “potential,” or similar words. Forward-looking statements are notguarantees of future performance, are based on certain assumptions, and aresubject to various known and unknown risks and uncertainties, many of which arebeyond the Company’s control, and cannot be predicted or quantified, and,consequently, actual results may differ materially from those expressed orimplied by such forward-looking statements. Such risks and uncertaintiesinclude, without limitation, risks and uncertainties associated with (i) ourinability to manufacture our product candidates on a commercial scale on ourown, or in collaboration with third parties; (ii) difficulties in obtainingfinancing on commercially reasonable terms; (iii) changes in the size andnature of our competition; (iv) loss of one or more key executives orscientists; and (v) difficulties in securing regulatory approval to proceed tothe next level of the clinical trials or to market our product candidates. Moredetailed information about the Company and the risk factors that may affect therealization of forward-looking statements is set forth in the Company’s filingswith the Securities and Exchange Commission (SEC), including the Company’sAnnual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investorsare urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publiclyupdate or revise its forward-looking statements as a result of new information,future events or otherwise.
Contact:
Andy An – Chief FinancialOfficer
765-610-8826
andyan@ambrivis.com
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