Tag: AllerDM

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: 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.

Company News: Anergis Files Provisional U.S. Patent on AllerDM Dust Mite Allergy Treatment

– Further expansion of the company’s product pipeline and patent estate –

Anergis, a company focusing on proprietary synthetic allergy vaccines designed to provide ultra-fast desensitization, has filed for provisional patent protection of its AllerDM dust mite allergy treatment in the U.S. The company plans to extend the patent application within the next 12 months to achieve world-wide protection under the Patent Cooperation Treaty.

AllerDM is an allergy vaccine for patients with house dust mite allergy and is based on Anergis’ proprietary Contiguous Overlapping Peptide (COP) technology, which allows for ultra-fast desensitization in only two months treatment. COP allergy vaccines are pharmaceutical quality products, which have proven to be safe and well tolerated and to induce a long-term immune effect. AllerDM is currently in pre-clinical development and is expected to enter clinical stage in 2015. Further details on the product are not being disclosed at present.

House dust mites are the most frequent cause of allergy and suspected to trigger severe consecutive disorders. Asthma may be caused by house dust mite allergy in 50 to 80% of patients. It is estimated that about 60 million patients in Europe, 30 million in the U.S., 20 million in Japan and 60 million in China suffer from dust mite allergies.

AllerT, the lead product of Anergis, is currently evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial in 240 patients with moderate to severe birch pollen allergy, enrolled at 24 trial centers throughout Europe. Results are expected in Q3, 2013.

Earlier this year, Anergis presented preclinical data of its ragweed allergy vaccine candidate AllerR. A Phase I/IIa trial of AllerR is expected to start in 2015.