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VITAL THERAPIES: Briefing Document For Proposed Vtl-308 Phase 3 Trial Submitted To Fda

The following excerpt is from the company's SEC filing.

The Company has submitted a briefing document including a draft trial protocol to the Food and Drug Administration (FDA) for the upcoming Type C written response meeting, from which the Company expects feedback by year end. This trial, to be known as VTL-308, is similar to the failed VTI-208 trial, but incorporates changes based on the promising subset data from VTI-208.

The proposed design excludes subjects aged 50 years or older and those with a MELD of 30 or higher. Considering the three components of MELD, subjects are also excluded with creatinine of 1.3 mg/dL or above, which limits kidney dysfunction, and international normalized ratio (INR) above 2.5, which limits blood coagulopathy. The third MELD component, bilirubin, has been raised to a minimum of 16 mg/dL to ensure that liver dysfunction is a major contributor to MELD. An intent-to-treat (ITT) post-hoc analysis of VTI-208 incorporating these parameters is shown below (this subset has a median MELD of 26.0 and a mean MELD of 25.6):

Figure 1. Kaplan Meier Curve of the Post Hoc VTI-208 Subset: age <50 years, MELD <30 and specific restrictions on MELD components (Creatinine < 1.3 mg/dL, INR ≤ 2.5, Bilirubin ≥ 16 mg/dL). Overall survival up to at least study day 91 (N=60; p<0.01. hazard ratio = 0.28).

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91-day survival in this post hoc analysis was 93% for the ELAD group versus 61% for those treated only with standard-of-care (Pearson's Chi-squared p<0.01). Moreover, the survival benefit appeared durable with survival at the end of 180 days of 89% for the ELAD group versus 48% in those treated only with standard-of-care (Pearson's Chi-squared p<0.01).

Although the result of this post hoc analysis showed statistical significance, it was not pre-specified and there is no guarantee that the results of the planned VTL-308 phase 3 trial will replicate the results of this subset.

VTL-308 is designed to enroll approximately 150 subjects and to be conducted at approximately 40 sites in the U.S., U.K., Ireland, Germany and Spain, comprised mostly of high enrolling sites from VTI-208. The Company has begun the process of opening clinical sites for VTL-308 and anticipates enrolling the trial’s first subject in the first half of 2016.

The Company is not requesting a Special Protocol Assessment (SPA) from FDA due to the open label design of the trial. The Company plans to submit a briefing package to the European Medicines Agency (EMA) to request scientific advice on VTL-308. The Company also plans to submit Clinical Trial Authorizations (CTAs) to each EU country expected to participate in the trial.

Presentation of VTI-208 Results at AASLD Meeting

Results of the VTI-208 trial have been accepted for oral presentation by the American Association for the Study of Liver Disease (AASLD) at some time between 3:00 and 4:30 PM Pacific time in the late breaking session at The Liver Meeting in San Francisco, CA on November 16, 2015. The presentation will be given by Principal Investigator David J. Reich, MD, professor and vice chairman of the Department of Surgery at Drexel University College of Medicine.

Employee Retention Program

The Board of Directors has approved an employee retention program that grants up to a total of 742,168 stock options (2.7% of total shares and options outstanding prior to these grants) to all employees and certain consultants. The key feature of this program is that the new stock options only vest after three years provided the VTL-308 trial is completed with a statistically significant result.

“VTL is fortunate to have outstanding employees who are motivated by participating in the development of an...