ABVC - ABVC BioPharma Completes Site Selection for ABV-1505 ADHD Phase II Part 2 Clinical Study
Completionof the Study Expected by the End of 2022
Fremont, CA - (NewMediaWire) - September 13, 2021 - ABVC Biopharma, Inc. (NASDAQ:ABVC), a clinical stage biopharmaceutical company developing therapeuticsolutions in oncology/hematology, CNS, and ophthalmology, today announced ithas completed clinical site selection for its ABV-1505 Attention-DeficitHyperactivity Disorder (ADHD) Phase II Part 2 study. The Phase II, Part 1 study, completed at the Universityof California, San Francisco, was accepted by the US Food & DrugAdministration in October 2020. The Part 2 study of ABV-1505 (ADHD) is amulti-nation multi-site randomized, double-blind, placebo-controlled studyinvolving approximately 100 patients.
The study sites selected are the University of California, SanFrancisco (UCSF) in the USA and five prestigious medical centers inTaiwan, including the National Taiwan University (NTU) Hospital, Cheng HsinGeneral Hospital, Linkou Chang Gung MemorialHospital, Kaohsiung Chang Gung Memorial Hospital, and Taipei VeteransGeneral Hospital. In parallel with the InstitutionalReview Board (IRB) submission at UCSF, a central IRB (cIRB) submission of theprotocol and study-related dossiers will be issued by ABVC in Q4, 2021 for allfive Taiwan sites. The study is targetedto begin in the first quarter of 2022.
“All of the principal investigators and sites selected are highlyregarded worldwide, for their work in the treatment of ADHD,” said Dr. HowardDoong, ABVC BioPharma’s chief executive officer. “We believe that the Phase IIPart 2 study, which we expect to be completed in late 2022, will providepreliminary proof of the efficacy and safety of ABV-1505.” Further, Dr. Doong emphasized the importanceof ABVC BioPharma’s focus on botanical sourcing in drug development. “Ourclinical trials continue to demonstrate that medicines derived from plants havesignificant therapeutic benefits with few - if any - side effects in treatingserious medical conditions.”
About ABVC BioPharma
ABVC BioPharma is a clinical-stage biopharmaceutical companywith an active pipeline of six drugs and one medical device(ABV-1701/Vitargus®) under development. For its drug products, it is focused onutilizing its licensed technology to conduct proof-of-concept trials throughPhase 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 theclinical trials through Phase III at various locations throughout the world.
Forward-Looking Statements
Clinical trials are in early stages, and there is noguarantee that any specific outcome will be achieved. This press releasecontains “forward-looking statements.” Such statements may be preceded by thewords “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,”“predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similarwords. Forward-looking statements are not guarantees of future performance, arebased on certain assumptions, and are subject to various known and unknownrisks and uncertainties, many of which are beyond the Company’s control, andcannot be predicted or quantified, and, consequently, actual results may differmaterially from those expressed or implied by such forward-looking statements.Such risks and uncertainties include, without limitation, risks anduncertainties associated with (i) our inability to manufacture our productcandidates on a commercial scale on our own, or in collaboration with thirdparties; (ii) difficulties in obtaining financing on commercially reasonableterms; (iii) changes in the size and nature of our competition; (iv) loss ofone or more key executives or scientists; and (v) difficulties in securingregulatory approval to proceed to the next level of the clinical trials or tomarket our product candidates. More detailed information about the Company andthe risk factors that may affect the realization of forward-looking statementsis set forth in the Company’s filings with the Securities and ExchangeCommission (SEC), including the Company’s Annual Report on Form 10-K and itsQuarterly Reports on Form 10-Q. Investors are urged to read these documentsfree of charge on the SEC’s website at http://www.sec.gov. TheCompany assumes no obligation to publicly update or revise its forward-lookingstatements as a result of new information, future events or otherwise.
This press release does notconstitute an offer to sell or the solicitation of an offer to buy thesesecurities, nor shall there be any sale of these securities in any state orjurisdiction in which such offer, solicitation or sale would be unlawful priorto registration or qualification under the securities laws of that state orjurisdiction.
Contact:
Andy An – Chief Financial Officer
765-610-8826