Valneva is now finalizing the detailed Phase 2 protocol and, subject to requisite regulatory approvals, expects to enter Phase 2 clinical development by the end of 2018. Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented “We appreciate the valuable and constructive guidance the FDA has provided and are looking forward to progressing into Phase 2. Lyme is a vaccine preventable disease. We are strongly committed to advancing our Lyme disease vaccine candidate as quickly as possible with the aim of preventing this severe and often debilitating infection.”
The Company will provide a full update on its Lyme program during the publication of its H1 results on August 2nd, 2018.
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 20186. 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 proprietary 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.