Tag: AllerT
Company News: Anergis Announces Completion of Treatment in AllerT Phase II Dose-Ranging Trial
– 213 patients included in trial of novel ultra-fast allergy immunotherapeutic
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced treatment completion of its Phase II clinical trial of AllerT, a novel long-peptide immunotherapeutic to treat birch pollen allergies. In the trial, 213 patients were randomized to receive target doses of 10, 25 or 50 µg of AllerT or placebo as 5 subcutaneous injections over 2 months. The last patient was treated at the end of March. No serious adverse events and no grade 3 or 4 allergic reactions were reported. The trial is being conducted in Canada and is still blinded. Results are expected in Q3 of 2015.
Company News: Anergis Starts Phase II Dose Ranging Trial with Birch Pollen Allergy Vaccine AllerT
– Dose assessment for upcoming Phase III trial
Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the start of a Phase II trial designed to finalize the dose selection for the Phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.
The randomized, double-blind, placebo-controlled, 4-parallel-group trial will assess the dose response efficacy of AllerT across doses of 50 µg, 25 µg, 10 µg compared to a placebo in an environmental exposure chamber (EEC). Approximately 180 birch pollen allergy patients will receive 5 subcutaneous injections over 2 months. All enrolled patients will be challenged with birch pollen prior to receiving AllerT or the placebo, and 4 weeks after the last injection.
The primary endpoint is the change in Total Rhinoconjunctivitis Symptom Scores (TRSS) from the baseline EEC challenge to the post-treatment EEC challenge.
Secondary endpoints are the mean Total Nasal Symptom Scores (TNSS), Total Ocular Symptom Score (TOSS), Individual Nasal Symptom Scores (NSS) and Asthma Symptom Score (ASS), which will also be evaluated from the baseline EEC challenge to the post-treatment EEC challenge. The trial is being conducted in Canada, with results expected in the third quarter of 2015.
Company News: Anergis Closes Series B Financing Round Totaling CHF 14.5 Million
– Two U.S.-based family offices join as new investors
– All Series A investors participate in the round
Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the closing of a Series B financing round totaling CHF 14.5 million (€ 12.1 million, US$ 15 million). All Series A investors participated in the round together with new private European and U.S.-based investors. The financing was jointly led by existing investors Sunstone Capital, BioMedInvest and Renaissance PME as well as new investor WJFS, Inc. Anergis has so far raised a total of CHF 44 million in private equity, which includes the latest Series B financing round.
The funds will be used to advance Anergis´ birch allergy vaccine AllerT closer to market. The company is currently preparing the Phase III clinical trial program of AllerT. Anergis has already demonstrated the rapid and long-lasting clinical efficacy of AllerT in two subsequent field-based clinical Phase II trials. The funds will also be used to advance the AllerR ragweed allergy program towards clinical testing, as well as to research and discover undisclosed new Contiguous Overlapping Peptide (COP) allergy vaccines.
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.