VBI Vaccines (VBIV) Granted FDA Approval of Investigational New Drug Application for Sci-B-Vac(R) Phase 3 Clinical Program

August 30, 2017 8:09 AM EDT

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-- Sci-B-Vac® is a third-generation hepatitis B vaccine, approved for use in Israel and 14 other countries

-- VBI expects to initiate enrollment in a Phase 3 clinical program later in the second half of 2017 in the U.S., Europe and Canada

VBI Vaccines Inc. (NASDAQ: VBIV) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug Application (IND) for a Phase 3 clinical program evaluating Sci-B-Vac®, VBI's third-generation hepatitis B vaccine. The company had previously received a No Objection Letter (NOL) from Health Canada in response to its Clinical Trial Application (CTA) as well. Acceptance of the IND and CTA enable the company to initiate the Phase 3 clinical study in both the U.S. and Canada.

"The receipt of formal acceptance of our clinical program from both the FDA and Health Canada marks a significant milestone as we move forward to initiating enrollment later this year in this Phase 3 pivotal program," said Jeff Baxter, President and CEO of VBI. "This program is expected to be conducted at approximately 40 sites across the U.S., Canada and Europe."

VBI previously announced the design of its 4,800-subject clinical program which will consist of two concurrent, 15-month Phase 3 studies - a safety and immunogenicity study (PROTECT) and a lot-to-lot consistency study (CONSTANT).

About PROTECT - Safety and Immunogenicity Study

PROTECT will be a double-blind, two-arm, randomized, controlled study. Approximately 1,600 adult subjects, age 18 years and older, will be randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac 10microng or a three-dose course of the control vaccine, Engerix-B® 20microng. Enrollment will be stratified by age group.

The co-primary objectives of the study will be:

--  To demonstrate non-inferiority of the seroprotection rate induced by
Sci-B-Vac vs. Engerix-B® four weeks after the third vaccination in
adults age 18 and older.
-- To demonstrate superiority of the seroprotection rate induced by Sci-B-
Vac vs. Engerix-B® four weeks after the third vaccination in adults
older than 45 years of age.

The study will also include multiple secondary objectives to evaluate the speed to seroprotection and the overall safety and tolerability of Sci-B-Vac vs. Engerix-B®.

About CONSTANT - Lot-to-Lot Consistency Study

CONSTANT will be a double-blind, four-arm, randomized, controlled study. Approximately 3,200 adult subjects, age 18-45 years, will be randomized in a 1:1:1:1 ratio to receive one of four three-dose courses: Lot A of Sci-B-Vac 10microng, Lot B of Sci-B-Vac 10microng, Lot C of Sci-B-Vac 10microng, or the control vaccine Engerix-B® 20microng.

The primary objective of this study will be:

--  To demonstrate lot-to-lot consistency for immune response as measured by
geometric mean concentration (GMC) of antibodies across three
independent, consecutive lots of Sci-B-Vac four weeks after the third
vaccination.

The secondary objective will be to evaluate safety and efficacy of Sci-B-Vac vs. Engerix-B®.

About Sci-B-Vac®

Sci-B-Vac® is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in more than 300,000 patients. Sci-B-Vac is currently approved for use in Israel and in 14 other countries. In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac may prove more immunogenic in subjects that currently do not respond optimally to second-generation vaccines.



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