Vital Therapies Announces VTL-308 Reaches 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
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.
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
These and other risks regarding our business are described in detail in our
Vice President, Investor Relations and Business Development
Source: Vital Therapies, Inc.