PDC-1421 high-dose data meets primary endpoint on MADRS scale in ITT clinical trial population
PDC-1421 low-dose and PDC-1421 high-dose each proved safe, were well-tolerated, and had no serious adverse events associated with them in Phase II clinical trial
Company is planning for end-of-Phase II meetings with regulatory authorities to discuss path forward for Phase III pivotal trials
FREMONT, CA, Nov. 14, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- American BriVision (Holding) Corporation (ABVC) (the “Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today issued a full clinical study report (CSR), under the U.S. Food and Drug Administration (FDA) and Taiwan FDA (TFDA) clinical protocol code of BLI-1005-002, for ABV-1504 major depressive disorder (MDD) Phase II study.
This study consisted of:
Part I - an open label, dose escalation study conducted in 12 adult patients for 4 weeks across multiple centers with PDC-1421 low-dose (380 mg) and PDC-1421 high-dose (2 x 380 mg), three times per day
Part II - a double-blinded and placebo-controlled trial conducted in parallel groups across 60 adult patients for 6 weeks in multiple centers and randomized (1:1:1) between PDC-1421 low-dose (380 mg), PDC-1421 high-dose (2 x 380 mg), and placebo, three times per day
The study was conducted by Stanford University and five major medical centers in Taiwan. PDC-1421 is the active pharmaceutical ingredient of ABV-1504.
The clinical study report (CSR) provided the following key study results:
PDC-1421 high-dose (2 x 380 mg) met the prespecified primary objective by demonstrating a highly significant 13.2-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in Intention-To-Treat (ITT) population, averaged over the 6-week treatment period from baseline (i.e., overall treatment effect), as compared to a 9.2-point reduction in the placebo group. In the per protocol population, the high-dose cohort had a 13.4-point reduction in MADRS as compared to an 8.6-point reduction in the placebo group.
In the ITT population, a greater reduction in net change in HAM-D-17 (Hamilton Depression Rating Scale-17) at week 6 was observed in the high-dose group (-10.95) compared to placebo group (-8.70). A significant group difference in net change in HAM-D-17 and HAM-A (Hamilton Anxiety Rating Scale) at week 2 was also found. Post-hoc, pair-wise comparisons demonstrated a significant difference between high-dose group and placebo group in HAM-D-17 (High dose -7.90 vs. Placebo -4.30; adjusted p = 0.039) and HAM-A (High dose -5.38 vs. placebo -2.90; adjusted p = 0.022), suggesting that subjects who took two PDC-1421 capsules three times per day showed greater improvement compared to those in the placebo group by week 2 (net change = 3.6 for HAM-D-17 and 2.48 for HAM-A).
Percentage of “responders” in MADRS at week 6 was highest in the high-dose group (High-dose vs. Placebo = 52% [n=11] vs. 35% [n=7] in ITT population; 53% [n=8] vs. 29% [n=4] in the per protocol population).
For the safety endpoint, both the low and high doses of PDC-1421 were safe and well tolerated with no serious adverse events.
“We believe that the Phase II results of our lead drug candidate PDC-1421 for MDD enable us to initiate End-of-Phase II meetings (EOP2) with the FDA and TFDA regulatory authorities to discuss Phase III and NDA-related plans and an eventual road map for market launch,” said Dr. Howard Doong, Chief Executive Officer of the Company.
As of March 2018 the World Health Organization has reported that more than 300 million people worldwide and of all ages suffer from MDD, also known as clinical depression. Figures from 2017 suggest that MDD affects over 17 million adults, or approximately 7% of the population over age 18, in the U.S., and it is the leading cause of disability in the U.S. for ages 15-44.
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