Tag: Christophe Reymond
Company News: Anergis Reports Positive Long-Term Clinical Efficacy of Lead Compound AllerT
– 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
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.
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.
Company News: Anergis Obtains Core Technology Patent in Japan
– Patent covers Contiguous Overlapping Peptide technology for the development of ultra-fast allergy vaccines –
Anergis, a company focusing on proprietary allergy vaccines, today announced it was granted a Japanese patent on its key technology from the Japanese Patent Office. The patent #5389326 broadly covers the Contiguous Overlapping Peptide (COP) technology which is used by Anergis to define and select new products for the ultra-fast treatment of multiple allergies.
“We have already been granted patents protecting our COP technology in the U.S. and Australia,” said Christophe Reymond, CSO of Anergis. “COPs are pharmaceutical quality products that provide the complete allergen sequence covering all T cell epitopes, but do not elicit allergic hypersensitivity. Therefore, COPs can be administered safely at high doses to induce tolerance to the allergen after a few injections only.”
He added that Anergis has already demonstrated in Phase I/IIa and IIb trials that just five injections of its lead COP allergy vaccine AllerT over a period of two months were sufficient to achieve long-lasting immunological effects as well as seasonal symptom reductions in allergic patients, similar to conventional allergy immunotherapy.
“Obtaining patent protection in Japan is an important milestone for Anergis because the Japanese population suffers from numerous allergies, particularly to house dust mites and to Japanese cedar,” said Vincent Charlon, CEO of Anergis.
Anergis’ COP technology can be applied to a broad spectrum of allergy indications. At present, Anergis is developing AllerT for the treatment of birch pollen allergy, AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.
Company News: Immunology Data Further Underline the Positive Outcome of a Phase IIb Trial of Anergis´ Birch Pollen Allergy Vaccine AllerT
– Treatment with AllerT increases allergen-specific IgG4 antibody levels by a factor of 20
– AllerT administration produces humoral immune responses similar to conventional desensitization
Anergis, a company focusing on proprietary allergy vaccines, today reported immunology data from the Phase IIb study of its lead compound AllerT. In the trial, AllerT induced a strong increase of allergen-specific IgG4, a key marker of immunological responses typically observed in successful, conventional allergy immunotherapy (AIT, previously known as allergen-specific immunotherapy, or SIT). In September 2013, Anergis had reported that the trial showed significant clinical effects of AllerT on multiple efficacy endpoints, including combined symptom and medication scores assessed daily throughout the natural birch pollen season 2013.
In the placebo-controlled, double-blind, multicenter trial, a total of 240 patients from 24 European trial centers were randomized to receive 5 pre-seasonal injections of AllerT 50 μg, AllerT 100 μg, or placebo over a period of 2 months between November 2012 and March 2013.
Allergen-specific IgG4 antibody blood levels were similar in all three groups before treatment. Four weeks after completion of treatment and prior to the birch pollen season, the IgG4 levels were markedly and similarly increased in both AllerT dose groups by a factor of about 20 compared to baseline and to placebo (all tests p < 0.0001). During the subsequent birch pollen season, the IgG4 levels remained similarly elevated in both dose groups, showing that a plateau of IgG4 had been reached. By contrast, IgG4 levels remained unchanged in the placebo group during treatment and during the pollen season.
Anergis’ COP (Contiguous Overlapping Peptide) technology can be applied to a broad spectrum of allergy indications. At present, Anergis is developing AllerT for the treatment of birch pollen allergy, AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.
Company News: Anergis Reports Positive Phase IIb Data for Birch Pollen Allergy Vaccine AllerT
– AllerT 50 μg meets primary and secondary endpoints
– Vaccine improves quality of life and symptom scores
Anergis, a company focusing on proprietary allergy vaccines, reported today that a Phase IIb study of its lead compound AllerT met the primary endpoint of reducing the combined symptom and medication score with AllerT 50 μg during the birch pollen season. Moreover, the vaccine improved the quality of life and symptom scores with AllerT 50 μg and AllerT 100 μg. AllerT is a birch pollen allergy vaccine derived from the company´s proprietary Contiguous Overlapping Peptide (COP) technology platform, which is designed to provide ultra-fast allergy desensitization after only two months of treatment.
In a placebo-controlled, double-blind, randomized multicenter trial, a total of 240 patients from 24 trial centers in Switzerland, France, Poland, Latvia, Lithuania, Sweden and Denmark were divided into three groups (placebo, AllerT 50 μg and AllerT 100 μg, respectively). From November 2012 to March 2013, the patients received 5 injections over a period of 2 months as a pre-seasonal treatment.
During the subsequent 2013 birch pollen season, compared to the placebo group, the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS, primary endpoint) was reduced by 30% (p=0.024, statistically significant) with AllerT 50 μg and by 19% (p=0.190, not statistically significant) with AllerT 100 μg. Both AllerT doses were associated with similar statistically significant improvements in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and in the rhinoconjunctivitis symptom score throughout the birch pollen season. All other secondary endpoints showed similar efficacy trends.
AllerT was safe and well-tolerated throughout the two-month pre-seasonal treatment. Most adverse events were mild or moderate, resolved within 24 hours, and there were no reports of anaphylactic shock or grade 3 allergic reactions within 30 minutes following any of the injections.
COP vaccines can be applied to a broad variety of allergy indications. Besides AllerT for the treatment of birch pollen allergies, Anergis´ COP allergy vaccine pipeline currently includes AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.