SAN DIEGO, March 22, 2018 (GLOBE NEWSWIRE) — Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of acute forms of liver failure, today announced that the VTL-308 phase 3 trial has reached its enrollment target of 150 subjects.
“We are delighted to report that we have reached target enrollment in VTL-308 before the end of the first quarter as expected,” said Russell J. Cox, the Company’s Chief Executive Officer. “We would like to thank the investigators in this trial and their staffs for enrolling the targeted population and for providing care to these subjects. We would also like to thank the patients and their families for participating in this unique cell therapy trial.”
VTL-308 is the Company’s phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe alcoholic hepatitis (sAH). The trial, which enrolled its first subject in May of 2016, was designed based on learnings from pre-specified and post-hoc analyses of the Company’s VTI-208 clinical trial. Subjects in VTL-308 were randomized 1:1 to either ELAD plus standard-of-care, or standard-of-care alone. The primary endpoint is overall survival through at least 91 days assessed using the Kaplan Meier statistical method.
The trial’s statistical plan incorporated an event-driven feature to allow for the extension of enrollment if a preliminary review of blinded data from VTL-308 was found to be inconsistent with prior expectations. During the first quarter of 2018, a review by independent statisticians concluded that the overall event rate experienced in VTL-308 subjects through year end 2017 was consistent with the trial’s original statistical plan, and therefore recommended the Company retain the trial’s original enrollment target of 150. The Company remains on track to report topline results for VTL-308 in the third quarter, likely in September.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting the treatment of acute forms of liver failure. The Company’s ELAD System is an extracorporeal human allogeneic cellular liver therapy currently in phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies® and ELAD® are trademarks of Vital Therapies, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying the success of our clinical trials, expectations regarding the achievement of the targeted number of events and the timing of the release of topline data. Forward-looking statements are based on current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on forward-looking statements.
Risks and uncertainties include, but are not limited to, the success or failure of our clinical trials; whether a single phase 3 clinical trial will be sufficient to support U.S. Food and Drug Administration approval of a biologics license application or whether the FDA will require us to conduct additional clinical trials; difficulty obtaining regulatory approval in the United States or Europe, in particular for a combination product with open-label clinical trials; final event rates may vary from earlier statistical projections and we may experience delays releasing topline data due delays in obtaining data, completing quality reviews and locking the data for all clinical sites within our expected timeframes. There can be no assurance that data from any of our clinical trials will be sufficient to support an application for marketing in any country or that any such application will ever be approved.
These and other risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-K for the quarter ended December 31, 2017. These forward-looking statements speak only as of the date hereof, and Vital Therapies, Inc. disclaims any obligation to update these statements except as may be required by law.
Vital Therapies, Inc.
Vice President, Investor Relations and Business Development