Merck (MRK) and partner Intercell AG recently announced that they have decided to terminate a phase II/III study that was being conducted with their investigational vaccine, V710. The vaccine was being studied for the prevention of staphylococcus aureus (S. aureus) infection.
The decision to terminate the study was based on the unanimous recommendation of an independent Data Monitoring Committee (DMC). Earlier in May, Merck and Intercell had stopped enrolment in the phase II/III study based on the recommendation of the DMC. At that time, the DMC had recommended that enrollment for the study be stopped pending further evaluation of the vaccine's benefits versus the attendant risks.
The DMC observed that V710 was unlikely to show a statistically significant clinical benefit compared to placebo. Moreover, the DMC expressed concern regarding the higher frequency of overall mortality and multi-organ dysfunction that occurred in the V710 group compared to the placebo group.
However, the safety difference was not statistically significant thereby not requiring any action beyond a routine safety follow-up. Detailed results from the study will be presented by Merck at an upcoming medical meeting.
The termination of the phase II/III study is a major setback for Intercell, which suffered another pipeline setback late last year when it had to scrap the development of its traveler’s diarrhea vaccine candidate. Given these pipeline disappointments, Intercell will now be primarily dependent on Ixiaro/Jespect, its Japanese encephalitis vaccine, for top-line growth.
V710 was being developed under an exclusive, worldwide agreement with Merck. Besides Merck, Intercell has collaborations with companies like Novartis (NVS) and GlaxoSmithKline (GSK) among others.
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