EMA’s comprehensive scientific advice is largely aligned with previous discussions with the US Food and Drug Administration (FDA) on the strategy for the VLA15 development and reaffirms the Company’s key development assumptions.
Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented, “Aligning with both the EMA and FDA bolsters our confidence in the development strategy for our Lyme disease vaccine candidate. We will continue to work very closely with regulatory authorities as we advance our vaccine, with the aim of protecting people from this often debilitating disease.”
The Company confirms it expects to enter Phase 2 clinical development at the end of 2018. Phase 2 will evaluate further dosages and schedules in addition to those evaluated in Phase 1. Based on the resulting immunogenicity and safety data, the final dose and schedule will be determined. It is expected that the Phase 2 will be conducted in approximately 800 subjects at more than 10 study sites in Lyme endemic areas in the U.S. and Europe. It is planned to include both study participants that have previously been exposed to Lyme as well as study participants that have not experienced previous infection. Phase 2 duration is expected to be approximately two years.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks. It is considered the most common vector borne illness in the Northern Hemisphere. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 300,000 Americans are diagnosed with Lyme disease each year with at least a further 200,000 cases in Europe. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system. The medical need for vaccination against Lyme disease is steadily increasing as the disease footprint widens.
Valneva’s vaccine candidate, VLA15, is currently the only active vaccine program in clinical development against Lyme disease. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 20175 and Valneva reported positive interim Phase 1 results in March 2018. VLA15 showed a favourable safety profile and was immunogenic in all doses and formulations tested with good OspA-specific IgG antibody responses against all OspA serotypes. VLA15 is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA)
of Borrelia. It is designed for prophylactic, active immunization against Lyme disease aiming for protection against the majority of human pathogenic Borrelia species.
VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. The safety profile is expected to be similar to other vaccines using the same technology that have been approved for active immunization in adults and children. The target population includes individuals at risk above 2 years of age living in endemic areas, people planning to travel to endemic areas to pursue outdoor activities and people at risk who have a history of Lyme disease (as infection with Borrelia does not confer protective immunity against all pathogenic Borrelia species). Vaccination with OspA was already proven to work in the 1990s and VLA15 pre-clinical data showed that the vaccine has the potential to provide protection against the majority of the Borrelia species pathogenic for humans. The global market for a vaccine against Lyme disease is currently estimated at approximately €700 - €800 million annually.
About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at www.valneva.com.