Date: 2014-09-16
Type of
information: Results
phase: 2b
Announcement: results
Company: Anergis (Switzerland)
Product: AllerT
Action
mechanism:
- immunotherapy product. 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. This technology reproduces the complete amino acid sequence of the allergen in separate synthetic long peptides. COP allergy vaccines provide the complete allergen sequence covering 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 at high doses to induce tolerance to the allergen after a few injections only. This allows for desensitization in 2 months as opposed to 3 years.
Disease: birch pollen allergy
Therapeutic
area: Allergic diseases - Immunological diseases
Country: Denmark, France, Latvia, Lithuania, Poland, Sweden and Switzerland
Trial
details:
- The AN004T trial is a multicentre, double-blind, placebo-controlled, randomized trial. It was designed in collaboration with an International Steering Committee of experts with comprehensive experience in the design and conduct of allergen-specific immunotherapy trials. 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. 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.
Latest
news:
- • On September 16, 2014, Anergis 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 ?g or AllerT 100 ?g 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 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. 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 fourthpost-treatment season (See below).
- • On April 23, 2014, Anergis announced that it has completed the enrolment of 196 subjects in the long-term efficacy trial of its birch pollen allergy vaccine AllerT, and expects to release results in the third quarter of 2014. The long-term efficacy trial of AllerT is a double-blind, placebo-controlled, field-based clinical trial assessing the persistence of the efficacy of AllerT in post-treatment years. All 196 patients participated in the field-based Phase IIb trial with AllerT in 2013. They all received a two-month double-blind, randomized treatment with AllerT or a placebo prior to the 2013 birch pollen season, and were then followed for efficacy during the 2013 birch pollen season, i.e. in conditions of natural pollen exposure. Last year’s Phase IIb trial had shown the efficacy of AllerT on allergy symptoms during the first post-treatment birch pollen season, based on combined symptom and medication scores, quality of life and other endpoints. In the new long-term efficacy trial, 196 patients were enrolled and agreed to collect their daily allergy symptoms and allergy medication using electronic diaries, exactly as was done during the previous trial/season. The patients have not received any further investigational treatment since their pre-seasonal two-month treatment in early 2013. The trial will thus provide efficacy data for AllerT during the second season post-treatment without any intervention since the initial two-month, pre-seasonal treatment. Anergis had already shown that patients from the AllerT Phase IIa trial had a persistent elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.
- • On October 21, 2013, Anergis has 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. 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 (See below). 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.
- • On September 10, 2013, Anergis has reported 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. In this 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 RSMS (Rhinoconjunctivitis Symptom and Medication Score - 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.
- These data confirm that COP allergy vaccines can substantially reduce allergy symptoms under real-life conditions. Anergis is now planning to proceed to a phase III study as soon as possible.
- • On November 6, 2012, Anergis has treated the first patient in a Phase IIb clinical trial in individuals with birch pollen allergy. The trial is designed to evaluate the efficacy and tolerability of a 5-injection / 2- months treatment with Anergis´lead allergy vaccine, AllerT. The first patient was randomized and treated on November 3rd, 2012, in Vilnius, Lithuania.
- Members of the AllerT Steering Committee are Prof. Dr. Frédéric De Blay (Hopitaux Universitaires de Strasbourg, France), Dr. Lars Jacobsen (Allergy Learning and Consulting, Denmark), Prof. Dr. Marek Jutel (Wroclaw Medical University, Poland), Prof. Dr. François Spertini (Centre Hospitalier Universitaire Vaudois, Switzerland) and Prof. Dr. Margitta Worm (Charité Universitätsmedizin Berlin, Germany).
Is
general: Yes
