Tag: ultra-fast allergy immunotherapeutics
Company News: Anergis Appoints Kim Simonsen as Chief Development Officer
– Senior Biotech Executive brings over 25 years of drug development expertise
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis´ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.
Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.
Prior to joining the biopharmaceutical industry in 1986, Mr. Simonsen trained as an MD at Copenhagen University and worked for five years at two different clinics in the Copenhagen area, focusing on internal medicine (gastroenterology, respiratory, cardiology). During his career, Mr. Simonsen has gained extensive experience in clinical drug development, including regulatory affairs, clinical pharmacology, and the design and management of clinical trials and pharmacovigilance. His expertise covers an extensive range of disease indications, incl. allergy immunotherapy, immunology, oncology, rheumatology, and cardiovascular and pulmonary diseases.
Company News: Anergis Presents Sustained Efficacy Data from its AllerT Phase IIb Trial at the AAAAI Annual Meeting
– Contiguous Overlapping Peptide allergy immunotherapeutic AllerT confirms sustained efficacy in the second year following treatment
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, presented detailed data from the Phase IIb trial of its birch pollen allergy immunotherapeutic AllerT in two separate scientific posters at the AAAAI (American Academy of Allergy, Asthma and Immunology) Annual Meeting in Houston, Texas. The findings were presented on February 22, 2015. Abstracts can be found at www.anergis.ch. AllerT is Anergis´ most advanced long-peptide immunotherapeutic and based on the company´s proprietary Contiguous Overlapping Peptide (COP) platform.
In 2013, the clinical efficacy of AllerT was demonstrated in a field-based, randomized, placebo-controlled, double-blind trial in 239 patients with birch pollen allergy, who received either AllerT (at 50μg or 100μg doses) or a placebo during a 2-month immunotherapy regimen. All main efficacy and safety endpoints were met in this study.
In 2014, the sustained efficacy of AllerT was assessed in the same group of patients during a second follow-up season without additional treatment. In both years, efficacy was evaluated using combined Rhinoconjunctivitis Symptom and Medication Scores (RSMS) as the primary endpoint as well as quality of life (Mini RQLQ) and Night-time Nasal Symptom Score (NNSS) as the main secondary endpoints. The study also measured the levels of allergen-specific immunoglobulins (Bet v 1 specific IgG4) in patients.
The data collected during the second post-treatment season (N=196 patients) proved the sustained efficacy of AllerT, as demonstrated by improvements in the primary endpoint, RSMS, and in the main secondary endpoints, Mini RQLQ and NNSS. The trial also confirmed that AllerT had induced a persistent elevation of anti-Bet v 1 IgG4 antibodies, i.e. measured after one year without treatment.