Tag: birch pollen vaccine

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 Completes Enrolment in the Long-Term Efficacy Trial of Lead Compound AllerT

– Results expected for Q3, 2014 –

Anergis, a company discovering and developing proprietary allergy vaccines, today 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, the enrolled patients 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.

Company News: Phase IIb Results of Anergis´ Lead Compound AllerT to be Presented at 2014 AAAAI Annual Meeting in San Diego

– Oral presentation scheduled for March 4, 2014 –

Anergis, a company discovering and developing proprietary allergy vaccines, today announced that the detailed Phase IIb results of its allergy vaccine AllerT will be presented during this year’s annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, CA. The oral presentation will be given by Prof. Francois Spertini, MD, Principal Investigator of the trial.

Presentation Title: “Ultra-Fast Hypoallergenic Birch Pollen Allergy Vaccine AllerT Is Efficient and Safe: Results Of a Phase IIb Study”

Time and Date: Tuesday, March 4, 2014, at 02:45pm PST.

Session: New Forms of Immunotherapy (session no. 5606)

Location: Convention Center, Mezzanine Level, Room 14AB

AllerT is a pharmaceutical-grade vaccine to treat birch pollen allergies via ultra-fast desensitization. The vaccine is based on the IP-protected Contiguous Overlapping Peptides (COP) technology.

Company News: Anergis Closes Financing Round Totaling CHF 8 M

– Preparation of Phase III trials with lead allergy vaccine AllerT

– Field-based, long-term efficacy milestone in patients from the AllerT Phase IIb trial coming up

Anergis, a company discovering and developing proprietary allergy vaccines, today announced the closing of a financing round totaling CHF 8 million. The financing was fully subscribed by existing investors and directors and was co-lead by Sunstone Capital, BioMedInvest and Renaissance PME/Vinci Capital.

Anergis will use the proceeds to further advance the clinical development of its lead product AllerT, a vaccine to treat birch pollen allergy, and to advance two additional vaccine candidates against house dust mite and ragweed allergies. For AllerT, the funds will specifically allow the preparation of Phase III trials and the conduct of a long-term efficacy follow-up trial of patients who participated in the recently completed field-based Phase II study. The results from this second follow-up season are expected to be available in the third quarter of 2014.

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