American BriVision Issues Clinical Study Report for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD)
November 09, 2020 at 09:00 AM EST
· PDC-1421, the active ingredient of ABV-1505, is being expanded into adult ADHD trials following encouraging Phase II trial results in major depressive disorder (MDD)
· Phase II Part I trial of ABV-1505 has been completed at the University of California, San Francisco (UCSF) Medical Center
· Phase II Part II trial of ABV-1505 will follow and also be conducted at UCSF
FREMONT, CA, Nov. 09, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- American BriVision (Holding) Corporation (OTCQB: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, central nervous system (CNS) and ophthalmology, today issued a full clinical study report (CSR) of its ABV-1505 Phase II Part I clinical trial conducted at the University of California, San Francisco (UCSF) for the treatment of adult Attention-Deficit Hyperactivity Disorder (ADHD).
Additionally, PDC-1421, the active pharmaceutical ingredient of ABV-1505, had been used recently in a Phase II clinical study conducted at Stanford University to successfully treat Major Depression Disorder (MDD).
The Phase II Part I clinical study for treating ADHD found that the PDC-1421 Capsule was safe, well-tolerated and efficacious during its treatment and follow-up period with six adult patients. For the primary endpoints, the percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline through eight weeks of treatment were 83.3% (N=5) in the Intention-To-Treat (ITT) population and 80.0% (N=4) in the Per-Protocol (PP) population. Both low and high doses of PDC-1421 Capsule met the primary end points by passing the required 40% population in ADHD-RS-IV test scores.
Overall, the results from this study, which demonstrate the therapeutic value of PDC-1421, support further clinical development of ABV-1505 for the treatment of adult ADHD.
“We are very pleased to see the safety, tolerability and efficacy of PDC-1421 capsule in low and high doses for the treatment of both MDD and adult ADHD,” said Dr. Howard Doong, Chief Executive Officer of American BriVision. “We expect the Phase II Part II trial of ABV-1505 to commence in Q2 of 2021 at UCSF and major medical centers in Taiwan.”
About American BriVision
American BriVision is a clinical-stage biopharmaceutical company 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). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. Past performance is not indicative of future results. Investments may be speculative and illiquid, and there is a risk of loss.
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. 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.
Andy An – Chief Financial Officer