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At first glance, an observer could have predicted that the actions in VBI Vaccines (Nasdaq: VBIV) would have increased based on the results of its PROTECT Phase III study, instead of decreasing by more than 60% as was the case on Monday. morning.
PROTECT Study Compares 10 μg Dose of US-Based Sci-B-Vac Trivalent Hepatitis B Vaccine to 20 μg of Comparison Vaccine, GlaxoSmithKline (LSE: GSK) Engerix -B.
The two co-primary endpoints were successfully met: non-inferiority in all adults aged ≥ 18 years and superiority in those aged 45 years or older.
But the study did not reach the secondary goal of non-inferiority of two doses of Sci-B-Vac at day 168, compared with three doses of Engerix-B at day 196 , in all subjects aged at least 18 years old.
Investors have clearly been frightened by this inability to achieve a critical secondary goal, which raises doubts about the North American and European prospects of a drug that will also face competition from the Dynavax 'Heplisav-B vaccine (Nasdaq : DVAX).
Sci-B-Vac has been approved in Israel and 10 other countries, but is under development III in North America and Europe.
Dynavax shares rose nearly 5% after the Monday morning trading.
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