Valneva updates on Phase II/III interim analysis of its Pseudomonas aeruginosa vaccine candidate

Biotech firm Valneva (Euronext: VLA), the company recently created through the merger of France’s Vivalis and Austria’s Intercell (The Pharma Letter May 14), has provided an update on the Phase II/III efficacy study interim analysis of its Pseudomonas aeruginosa vaccine candidate.

The development partners – Valneva and Novartis Vaccines & Diagnostics, a unit of Swiss drug major Novartis (NOVN: VX) - have initiated discussions on trial continuation in agreement with the recommendations of a Data Monitoring Committee (DMC) following their data review on the primary efficacy endpoint and safety data from 394 patients.

Although the stringent pre-specified futility criterion in regards to the primary efficacy endpoint was formally met, the difference in all-cause mortality rates (at Day 28) between the vaccine and placebo group in this randomized, placebo controlled double blind study, was considered clinically meaningful and in line with the trend observed in the previous study. Additionally there were no concerns with regard to the observed safety profile.