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August 19, 2022
The Nantes-based company Valneva has been working for several years on the development of a vaccine against Lyme disease. After signing an agreement with the Pfizer laboratory, it should be marketed within a few years. The two companies announced, in August 2022, the initiation of a phase 3 clinical study, the last before the applications for marketing authorization.
A vaccine against Lyme disease commercialized in a few years? This is the hope of the Valneva company, based in Nantes, which has just passed an agreement with the American giant Pfizer.
According to information from Ouest France, the laboratory will provide “114 million euros in initial payment. To this must be added 176 million, later, in milestone payments, and finally 19% royalties (license fees), at a minimum, on sales“.
The potential vaccine is titled VLA15. This is a “multivalent protein subunit vaccine targeting Borrelia outer surface protein A (OspA), a recognized mechanism of action for a Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by bacteria when present in a tick“, can we read on the Valneva website.
It is at present the only active clinical program in the fight against Lyme disease. He benefits from “fast track” statusby the American health authority, which speeds up regulatory procedures. The first results of the phase II study are expected in July.
Lyme disease is an infectious disease caused by the bacteria Borrelia burgdorferi, transmitted by ticks. In France in 2018, Public Health France recorded 104 cases per 100,000 inhabitants, an increase compared to 2017.
It evolves in three main phases, separated by asymptomatic periods.
- The first is characterized by a skin lesion: erythema chronicum migrans (ECM). General manifestations (headaches, joint pain, slight rise in body temperature, fatigue) and lymph nodes close to the skin lesion may be associated, reflecting the dissemination of the bacteria in the body;
- Then in the secondary phase, skin, joint, neurological and cardiac manifestations may appear;
- In the tertiary phase, the disease causes skin, joint and neurological damage.
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