Allergy Therapeutics, a UK-based specialist in allergy vaccines, has completed randomization with 364 patients entered into the PQBirch204 double-blind, placebo-controlled dose selection study for the specific subcutaneous immunotherapy (SCIT), Pollinex Quattro Birch.
According to the company, the target sample size of 350 patients randomized into 6 dosage arms and placebo has been successfully achieved, ending the recruitment phase of this study.
PQBirch204 is planned to complete by February, 2016 with results available in Q2 2016, Allergy Therapeutics added.
The endpoint of the trial is change in total rhynoconjunctival system score over baseline compared to placebo. The dose established as most efficacious, safe and tolerable will be selected and studied in the PQBirch phase III study, due to start in Q1 2017. The completion of the phase III study is expected to fulfill the requirements for the initial clinical programme under the Therapy Allergens Ordinance of the Paul Ehrlich Institute, the European Biologics Agency, and lead to Marketing Authorization Approval of this SCIT in 2019.
Manuel Llobet, CEO of Allergy Therapeutics, said:
“We are excited to be progressing development for another potential product in our ultra-short course, aluminium-free Pollinex Quattro portfolio. This Phase II trial for treatment for birch pollen allergy should read out in the second quarter 2016 and will determine the dose for a subsequent pivotal trial in this setting, which is earmarked to begin at the beginning of 2017.”
“Allergy to birch pollen is a significant health issue with around 6% of the population in Europe being skin-prick positive for the allergen.”