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Field-based trial with 196 patients shows significant reductions in seasonal allergy symptoms
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Efficacy of AllerT in both dose groups maintained during the second birch pollen season
EPALINGES, Switzerland, I September 16, 2014 I Anergis, a company developing proprietary ultra-fast allergy vaccines, today reported positive long-term efficacy results with its lead compound AllerT, a novel birch pollen allergy vaccine.
A total of 196 patients were enrolled in the Phase IIb follow-up, double-blind, placebo-controlled, field-based clinical trial. The trial objective was to evaluate the long-term efficacy of AllerT in patients who had participated last year in the field-based Phase IIb trial with AllerT. Patients evaluated this year either received a placebo, AllerT 50 µg or AllerT 100 µg 18 months before the second birch pollen season. No further investigational treatment was given after the initial randomization.
Subjects who had received AllerT showed persistent, statistically significant (p<0.05) and clinically meaningful (>20% difference from placebo) reductions in the primary (combined symptom and medication score) and main secondary endpoints (quality of life score and nighttime nasal symptoms). The results were remarkably consistent across all clinical endpoints and did not show meaningful differences between Year 1 and Year 2 clinical responses. In addition, the clinical effects of both doses were very similar.
Full results of the trial will be presented at an upcoming scientific conference.
“With this trial, we have confirmed our first year efficacy results and have demonstrated that a 2-month treatment with AllerT can produce long-term clinical benefits under conditions of natural allergen exposure,” said Vincent Charlon, CEO of Anergis. “The combination of these new clinical data with previously demonstrated long-lasting antibody responses strongly suggests that COP allergy vaccines have a disease-modifying effect in patients suffering from allergies.”
In 2013, Anergis had already shown that patients from the AllerT Phase IIa trial had a long-lasting elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.
About Anergis
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel, proprietary allergy vaccines that target commercially attractive indications. Anergis´ vaccines are based on its IP-protected Contiguous Overlapping Peptide (COP) technology. Allergies are the most prevalent and fastest growing chronic conditions in the industrialized world affecting over 500 million people.
Anergis’ lead-product AllerT, a vaccine to treat birch pollen allergies, is due to enter Phase III clinical development. Two additional vaccine candidates against ragweed pollen allergies (AllerR) and house dust mite allergies (AllerDM) are in preclinical development.
Anergis has raised over CHF 30 million from Renaissance PME/Vinci Capital, Sunstone Capital, BioMedInvest and other investors, including Esperante Ventures and Initiative Capital Romandie.
About Anergis´ Contiguous Overlapping Peptides (COP) Technology
The only curative therapy of allergies available today, known as “desensitization” or “Conventional Allergy Immunotherapy” (AIT), is the process of inducing tolerance to the allergen. It requires 3-5 years of treatment and exposes patients to the risk of serious side effects – in particular immediate (<30 min) anaphylactic reactions – which can be life-threatening. With its ultra-fast desensitization, Anergis is shaping the future of allergy treatment. Anergis’ vaccines are based on COPs which reproduce the complete amino acid sequence of the allergen in separate synthetic long peptides. COP allergy vaccines are pharmaceutical quality products that provide the complete allergen sequences of all T cell epitopes, but do not cross-react with IgE, the antibody class responsible for eliciting allergic hypersensitivity. Therefore, COPs can be administered safely independent of MHC restriction and at high doses to induce tolerance to the allergen after only a few injections. This enables desensitization in 2 months as opposed to 3 years. Studies of COPs targeting bee venom and birch pollen allergies in both animals and humans have demonstrated excellent safety (i.e. no immediate allergic reaction) and immunogenicity (production of specific antibodies and cytokines against the original allergen and establishment of a long-term immune memory).
SOURCE: Anergis
Post Views: 154
-
Field-based trial with 196 patients shows significant reductions in seasonal allergy symptoms
-
Efficacy of AllerT in both dose groups maintained during the second birch pollen season
EPALINGES, Switzerland, I September 16, 2014 I Anergis, a company developing proprietary ultra-fast allergy vaccines, today reported positive long-term efficacy results with its lead compound AllerT, a novel birch pollen allergy vaccine.
A total of 196 patients were enrolled in the Phase IIb follow-up, double-blind, placebo-controlled, field-based clinical trial. The trial objective was to evaluate the long-term efficacy of AllerT in patients who had participated last year in the field-based Phase IIb trial with AllerT. Patients evaluated this year either received a placebo, AllerT 50 µg or AllerT 100 µg 18 months before the second birch pollen season. No further investigational treatment was given after the initial randomization.
Subjects who had received AllerT showed persistent, statistically significant (p<0.05) and clinically meaningful (>20% difference from placebo) reductions in the primary (combined symptom and medication score) and main secondary endpoints (quality of life score and nighttime nasal symptoms). The results were remarkably consistent across all clinical endpoints and did not show meaningful differences between Year 1 and Year 2 clinical responses. In addition, the clinical effects of both doses were very similar.
Full results of the trial will be presented at an upcoming scientific conference.
“With this trial, we have confirmed our first year efficacy results and have demonstrated that a 2-month treatment with AllerT can produce long-term clinical benefits under conditions of natural allergen exposure,” said Vincent Charlon, CEO of Anergis. “The combination of these new clinical data with previously demonstrated long-lasting antibody responses strongly suggests that COP allergy vaccines have a disease-modifying effect in patients suffering from allergies.”
In 2013, Anergis had already shown that patients from the AllerT Phase IIa trial had a long-lasting elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.
About Anergis
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel, proprietary allergy vaccines that target commercially attractive indications. Anergis´ vaccines are based on its IP-protected Contiguous Overlapping Peptide (COP) technology. Allergies are the most prevalent and fastest growing chronic conditions in the industrialized world affecting over 500 million people.
Anergis’ lead-product AllerT, a vaccine to treat birch pollen allergies, is due to enter Phase III clinical development. Two additional vaccine candidates against ragweed pollen allergies (AllerR) and house dust mite allergies (AllerDM) are in preclinical development.
Anergis has raised over CHF 30 million from Renaissance PME/Vinci Capital, Sunstone Capital, BioMedInvest and other investors, including Esperante Ventures and Initiative Capital Romandie.
About Anergis´ Contiguous Overlapping Peptides (COP) Technology
The only curative therapy of allergies available today, known as “desensitization” or “Conventional Allergy Immunotherapy” (AIT), is the process of inducing tolerance to the allergen. It requires 3-5 years of treatment and exposes patients to the risk of serious side effects – in particular immediate (<30 min) anaphylactic reactions – which can be life-threatening. With its ultra-fast desensitization, Anergis is shaping the future of allergy treatment. Anergis’ vaccines are based on COPs which reproduce the complete amino acid sequence of the allergen in separate synthetic long peptides. COP allergy vaccines are pharmaceutical quality products that provide the complete allergen sequences of all T cell epitopes, but do not cross-react with IgE, the antibody class responsible for eliciting allergic hypersensitivity. Therefore, COPs can be administered safely independent of MHC restriction and at high doses to induce tolerance to the allergen after only a few injections. This enables desensitization in 2 months as opposed to 3 years. Studies of COPs targeting bee venom and birch pollen allergies in both animals and humans have demonstrated excellent safety (i.e. no immediate allergic reaction) and immunogenicity (production of specific antibodies and cytokines against the original allergen and establishment of a long-term immune memory).
SOURCE: Anergis
Post Views: 154
