HAL Allergy B.V. today announced that it has successfully completed patient enrollment in its Phase II trial with SUBLIVAC® FIX Phleum pratense. This combined dose tolerability and dose range finding study will characterize the dose-response relationship of SUBLIVAC® FIX Phleum pratense in order to support the optimal dose in terms of clinical efficacy and safety for further investigation in Phase III studies.
This multi-centre, randomized, double-blind, placebo-controlled study in patients with persistent allergic rhinitis / rhinoconjunctivitis was initiated in September 2012 and will be completed in May 2013. More than 250 patients were included in 23 clinical sites in Germany and Poland. The completion of enrollment is an important milestone in the clinical development program of SUBLIVAC® FIX Phleum pratense.
"Together with the ongoing studies with PURETHAL® Mites and SUBLIVAC® FIX Birch this is the third dose range finding study within a period of one year for which we have completed patient enrollment. All three studies are part of our state-of-the-art clinical trial program to support final licensure of the products under the enactment of the German Regulation on Therapy Allergens (i.e., "Therapieallergene-Verordnung"). The on time patient enrollment for all three studies demonstrates that we are fully committed and capable to meet the goals of this program. Results will be available mid-2013, subsequently, the first Phase III pivotal trials will be initiated in 2014" says Harry Flore , CEO of HAL Allergy.