Valneva's C. diff vaccine found to be 'highly immunogenic' in PhII

Racing against big-name vaccines players, Valneva reported positive Phase II results this week for its GlaxoSmithKline-partnered C. difficile vaccine candidate, saying the shot proved to be "highly immunogenic" while also offering a good safety and tolerability profile.

Valneva CEO Thomas Lingelbach

The trial, conducted in Germany and the United States, tested the vaccine candidate in 500 volunteers separated into two age groups: 50 to 64 and 65 and above. Researchers reported that the vaccine was immunogenic at all doses and formulations tested, with a high-dose formulation containing no adjuvant generating a superior response. With the results, the Lyon, France-headquartered company said it'll announce further development steps after its final Phase II closeout in Q2 2016.

Typically occurring after antibiotic use, C. diff commonly affects older adults in hospitals or long-term care facilities. According to Valneva CEO Thomas Lingelbach, C. diff "has become the most frequent hospital-acquired infection and is now linked to almost 30 thousand deaths every year in the U.S. alone."

To date, no vaccines are available for any leading healthcare-related pathogens, which cost the U.S. healthcare system $9.8 billion annually, JAMA Internal Medicine has reported. In its statement, Valneva said it estimates that the market potential for preventive C. diff products could exceed $1 billion annually.

But competition for that market is heavy. Valneva is competing against Sanofi ($SNY), Pfizer ($PFE) and others in the race to develop a viable vaccine against the infection. Sanofi recently began a 200-site Phase III trial of its fast-tracked C. diff vaccine, while Pfizer's candidate is also fast-tracked but in Phase II. In the broader area of healthcare-related pathogens, Astellas recently started a company with ClearPath Development focused on creating vaccine candidates.

In 2007, Valneva entered its C. diff partnership with Novartis ($NVS), which was transferred to GlaxoSmithKline ($GSK) at the beginning of this year.

- here's the release