American BriVision Conducts Site Monitoring Visit for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD)

  • 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)
  • A site monitoring visit for the on-going Phase II Part I trial of ABV-1505 for the treatment of Adult ADHD was conducted at the University of California, San Francisco (UCSF) Medical Center on March 10 and 11, 2020
  • Phase II Part II trial of ABV-1505 is expected to follow Part I and be conducted at UCSF and major medical centers in Taiwan

FREMONT, CA, April 06, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – American BriVision (Holding) Corporation (OTCQB: ABVC) (the “Company”), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS and ophthalmology, today announced that a site monitoring visit was conducted on March 10 and March 11, 2020 at the University of California San Francisco (UCSF) Medical Center for  ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for Adult Attention-Deficit Hyperactivity Disorder (ADHD). 

This trial is an open label, single-center and dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive a low-dose treatment (380 mg) of PDC-1421 Capsules three times daily for 28 days followed by a high-dose treatment (760 mg) three times daily for another 28 days. 

As of the site monitoring visit, four qualified adult ADHD patients had been enrolled and treated with PDC-1421 Capsules. Among them, two will complete their treatment of PDC-1421 according to the study protocol on April 8 and April 11, 2020 respectively. The overall site monitoring visit went well with several minor errors cited and corrected subsequently. 

The primary objective of this study is to determine the effective doses and treatment period of PDC-1421 Capsules in adult patients with ADHD. The secondary objective is to evaluate the conditions of the patients receiving the drug at various dose levels. A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, assuming successful completion of this Phase II Part I study.

“We are pleased to announce that our Phase II Part I trial of ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) is proceeding at the University of California, San Francisco (UCSF) Medical Center,” said Dr. Howard Doong, Chief Executive Officer of the Company.

According to Grand View Research, the global ADHD market size was valued at $16.4 billion in 2018 and is estimated to exhibit a compound annual growth rate of 6.4% through 2025, driven by worldwide drug product approvals and launches and increased research and development activities.

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.

Disclaimer

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. 

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This document contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; our having adequate funding to conduct our clinical trials; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this document and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this document, and other statements made from time to time by us or our representatives that might occur.

Contact:
Andy An – Chief Financial Officer
765-610-8826
andyan@ambrivis.com

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