Date: 2016-05-09
Type of
information: Results
phase: 2
Announcement: results
Company: Allergy Therapeutics (UK)
Product: Pollinex Quattro Birch
Action
mechanism:
- immunotherapy product. Pollinex Quattro is an allergen-specific immunotherapy that comprises three key technologies tailored to reduce irritation and systemic reactions; modified allergens, microcrystalline tyrosine (MCT) and Monophosphoryl lipid A (MPL).
The ultra-short duration of Pollinex Quattro is achieved via allergen modification that transforms the structure of allergens to allow increased doses to be delivered compared to traditional unmodified preparations. The potent depot adjuvant, MCT, has a Th1 immunomodulating action that acts in synergy with the TLR4 receptor agonist MPL to augment a shift in the immune reactions responsible for the symptoms of allergic rhinitis.
Disease: birch pollen induced seasonal allergic rhinitis
Therapeutic
area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details:
Latest
news:
- • On May 9, 2016, Allergy Therapeutics announced positive top-line results from its PQBirch204 Phase II study, a multi-centre, double-blind, placebo-controlled study designed to explore the safety and response of different cumulative doses of Birch Modified Allergen Tyrosine adsorbed and MPL® (POLLINEX® Quattro Birch) for birch pollen induced seasonal allergic rhinitis. The study randomised 371 patients into six cumulative dosing regimens plus a placebo, evaluating the change in Total Symptom Score (TSS) following a conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.
· The primary endpoint, to demonstrate a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300 SU, was met. This enables prediction of the dose to enter Phase III development
· The study demonstrated a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300SU dose range studied
· The dose-response closely followed and extended the findings of the previous dose-response study (PQBirch203), which studied doses from 600SU to 13600SU
· PQBirch continues to be well-tolerated and no safety concerns were reported in any treatment arm. There was no significant relationship between any adverse drug reaction exhibited and the respective dosage of allergoid
· Overall adherence to the dosing regimens was approximately 94% with no relevant differences between treatment arms.
- • On November 30, 2015, Allergy Therapeutics announced that it has completed randomisation with 364 patients entered into the PQBirch204 double-blind, placebo-controlled dose selection study for the specific subcutaneous immunotherapy (SCIT), Pollinex Quattro Birch. The target sample size of 350 patients randomised 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.
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 fulfil 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 Authorisation Approval of this SCIT in 2019.
Is
general: Yes
