Tag: AllerT
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.
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.