Anergis Starts European Phase IIb Clinical Trial With AllerT in Patients With Moderate to Severe Allergy to Birch Pollen
Published: Nov 06, 2012
The multicentre, double-blind, placebo-controlled, randomized trial called AN004T was designed in collaboration with an International Steering Committee of experts with comprehensive experience in the design and conduct of allergen-specific immunotherapy trials(1). The trial will enroll about 300 patients with moderate to severe birch pollen allergy from up to 30 trial centers throughout Europe. Trial centers are located in Denmark, France, Latvia, Lithuania, Poland, Sweden and Switzerland. AN004T will evaluate the efficacy and safety of two doses of AllerT in comparison with placebo. The first patient was randomized and treated on November 3rd , 2012, in Vilnius, Lithuania.
As recommended by the European Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases (CHMP/EWP/18504/2006), the efficacy of AllerT will be assessed using a combined symptom and medication score as primary endpoint of the trial (combined Rhinoconjunctivitis Symptom and Medication Score RSMS). RSMS assessment is based on allergy symptom and medication data reported through electronic diaries by the trial subjects during the 2013 birch pollen season. Secondary and exploratory endpoints will include other clinical parameters related to symptoms and/or medications taken for allergy, as well as quality of life and immunological marker assessments.
“This clinical Phase IIb trial with AllerT is conducted according to the most up-to-date regulatory requirements for allergen-specific immunotherapy clinical trials,” said Vincent Charlon, CEO of Anergis. “With clinical efficacy assessments based on combined symptom and medication scores under real-life conditions during the birch pollen season, the trial will provide the most relevant efficacy data for the design of the Phase III trials and the future registration of AllerT.”
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel allergy vaccines targeting the most frequent allergies. Anergis´ vaccines are based on its proprietary Continuous Overlapping Peptides technology. Allergies are the most prevalent and the fastest growing chronic conditions in the industrialized world, with over 300 million people affected.
Anergis’ lead-product AllerT, a vaccine to treat birch pollen allergies, is in Phase II clinical development. AllerR, its second vaccine candidate for the treatment of patients with allergy to ragweed pollen, has recently reached important preclinical milestones and received positive feedback from the U.S. FDA for the subsequent clinical development program in June 2012. Anergis has raised over CHF 20 million from Vinci Capital, Sunstone Capital, BioMedInvest and other investors including Esperante Ventures and Defi Gestion. About Anergis´ Contiguous Overlapping Peptides Technology (COPs)
The only curative therapy of allergies available today, known as “desensitization” or “Specific Immunotherapy” (SIT), is a process of induction of tolerance to the allergen requiring 3-5 years of treatment and exposing patients to the risk of serious side effects. Anergis has developed a next-generation concept of SIT: vaccines based on COPs (Contiguous Overlapping Peptides), which reproduce the full-length amino acid sequence of the allergen in separate long peptides. COPs do not cross-react with IgE, the antibody class responsible for eliciting allergic hypersensitivity. Therefore, COPs can be safely administered at high doses to induce tolerance to the allergen after few injections only. Studies of COPs targeting bee venom and birch pollen allergies in both animals and humans have demonstrated excellent safety (no immediate allergic reaction) and immunogenicity (production of specific antibodies and cytokines against the original allergen and establishment of a long term immune memory).
Vincent Charlon, CEO
Dr. Ludger Wess, Ines Regina Buth
Tel. +49 40 88165964 or +49 30 2363 2768