In short
Olea europaea pollen, depigmented polymerized extract is an investigational allergen immunotherapy substance studied for allergic rhinoconjunctivitis with or without asthma caused by grass and olive pollen. It is given as a subcutaneous injection in a fixed-combination product called Depigoid DUO Grass-Mix/Olea. One authorised Phase 3 trial is testing it against placebo in 343 participants.
Key points
- Phase 3 trial of depigmented polymerized olive and grass pollen extract in allergic rhinoconjunctivitis with or without asthma.
- The trial is authorised and plans to enrol 343 participants.
- Treatment is given by subcutaneous injection; the trial requires at least 8 injections before evaluation.
- The main measure is the combined symptom and medication score (cSMS, 0–6) during peak pollen season.
- The product, Depigoid DUO Grass-Mix/Olea, is an investigational fixed combination with no marketing authorisation in these records.
What is Olea europaea pollen, depigmented polymerized extract?
Olea europaea pollen, depigmented polymerized extract is an allergen immunotherapy substance. It is prepared from olive tree pollen that has been depigmented and polymerized, a process intended to reduce the risk of allergic reactions while keeping the ability to train the immune system. In the registered trial, the substance appears as part of a fixed combination product named Depigoid DUO Grass-Mix/Olea, which also contains depigmented polymerized extracts of five grass pollens: Phleum pratense, Festuca elatior, Dactylis glomerata, Poa pratensis and Lolium perenne.
The development company is LETI PHARMA, S.L.U. The product records show no marketing authorisation, meaning the substance is still investigational.
How does Olea europaea pollen extract work?
As an allergen immunotherapy, the extract is designed to expose the immune system to small, controlled amounts of the allergen over time. The goal is to shift the immune response away from the allergic reaction that causes symptoms. The depigmented and polymerized form is intended to reduce allergenicity while preserving the ability to induce tolerance. The registered trial does not describe a specific molecular target; the information available concerns the clinical testing of the product.
Which conditions is it used or studied for?
- Allergic rhinoconjunctivitis with or without asthma — inflammation of the nose and eyes caused by allergy, sometimes accompanied by asthma, due to clinically relevant sensitisation to grass and olive pollen.
The therapeutic area of the trial records covers respiratory tract diseases and immune system diseases.
How is Olea europaea pollen extract given?
The product is a suspension for injection given by subcutaneous injection, meaning it is injected under the skin. In the registered trial, the dose is 0.5 ml of Depigoid DUO Grass-Mix/Olea at a strength of 1000 DPP/ml for each component (grass mix and olive).
What do the clinical trials show?
One trial is registered for this substance. The GOES trial (Grass/Olive Immunotherapy for Rhinitis and Asthma) is a Phase 3, interventional, placebo-controlled study. It is currently authorised, with a planned enrolment of 343 participants.
The trial compares active treatment with placebo, which is the solvent used in the investigational product formulation. Participants receive at least 8 injections before the main evaluation. The primary outcome is the combined symptom and medication score (cSMS, 0–6) collected through a mobile app during the peak of grass and olive pollination. The medication score ranges from 0 (no medication) to 1.5 (intranasal corticoid), and the symptom score from 0 (none) to 3 (severe) for six symptoms: runny nose, sneezing, itchy nose, nasal congestion, itchy eyes and tearing.
The trial also uses conjunctival provocation tests with Olea europaea and grass mix extracts at 30 HEP/ml as part of the assessment.