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As of October 24th, the VTL-308 trial was 79% enrolled based on its target of at least 150 subjects and the Company is expecting to report topline data in the third quarter of next year. 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). 118 subjects were enrolled in the trial with 45 sites open for enrollment. Since the Company’s last quarterly update reported on August 3, 2017, enrollment has continued at a rate of more than 8 subjects per month at sites in the United States and Europe. If it is decided more than 150 subjects are needed to reach 55 deaths under the event-driven design of the trial, the topline data could be delayed.
Today, the Company has updated the baseline characteristics of subjects enrolled in VTL-308 to include the first 115 subjects. The data continue to show that the means for these baseline characteristics continue to track the reference population from VTI-208, the Company’s prior phase 3 clinical trial with ELAD in subjects with sAH on which the design of VTL-308 is based. The updated baseline data are presented in the table below:
VTL-308 enrollment limits
VTI-208 reference population
(28 - 49)
(20 - 29)
(16.6 - 52.6)
(1.0 - 2.5)
(0.10 - 1.30)
(23 - 49)
(19 - 29)
(16.0 - 44.7)
(0.95 - 2.50)
(0.30 - 1.27)
During the quarter the Company made a number of poster presentations at scientific meetings, including a presentation titled “Elaborating ELAD Mechanism of Action and Linking Cell-Based Models to the Clinic” made on September 9, 2017 at a conference in Rostock, Germany. The key finding was that levels of interleukin-1 receptor antagonist, or IL-1Ra, were significantly elevated during ELAD treatment compared with controls in a selected group of 25 subjects from the Company’s prior VTI-208 study who met the enrollment criteria for VTL-308. IL-1Ra is an anti-inflammatory protein that blocks the interaction of the pro-inflammatory cytokine, IL-1, with its receptor, thereby potentially reducing inflammation. Posters and associated presentations are made available at http://ir.vitaltherapies.com in the "Clinical Publications and Presentations" section promptly after they have been made publicly.
The following information was filed by Vital Therapies Inc (VTL) on Wednesday, October 25, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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