In short
Dermatophagoides farinae, depigmented/polymerized extract is an investigational allergen immunotherapy product derived from house dust mites. It is being studied as a subcutaneous injection to treat allergic rhinoconjunctivitis, with or without controlled asthma, caused by dust mites. The clinical data includes one authorised Phase 3 trial with a planned enrollment of 410 participants, comparing two strengths of the product against placebo.
Key points
- Dermatophagoides farinae, depigmented/polymerized extract is an investigational allergen immunotherapy for house dust mite allergy.
- It is studied in a Phase 3 trial with a planned enrollment of 410 participants.
- The trial addresses allergic rhinoconjunctivitis with or without controlled asthma.
- It is given as a subcutaneous injection in two strengths: 50 DPP/ml and 150 DPP/ml.
- The primary measure is the change in the combined symptom and medication score (cSMS) after 12 doses.
- The trial is currently authorised but not yet completed.
What is Dermatophagoides farinae, depigmented/polymerized extract?
Dermatophagoides farinae, depigmented/polymerized extract is an allergen immunotherapy product derived from the house dust mite Dermatophagoides farinae. It is a protein-based biological substance, prepared as a suspension for injection. The product is not an authorised medicine; it is an investigational substance with no marketing authorisation in the product records. It is supplied by LETI PHARMA, S.L.U. under the product names Depigoid Mite-Mix (50 DPP/ml + 50 DPP/ml) and Depigoid FORTE Mite-Mix (150 DPP/ml + 150 DPP/ml). The product is a fixed combination containing extracts of both Dermatophagoides pteronyssinus and Dermatophagoides farinae.
How does it work?
Allergen immunotherapy works by repeatedly exposing the immune system to small, controlled amounts of the allergen. The depigmented and polymerized extract is designed to reduce the allergenicity while maintaining the ability to stimulate a protective immune response. Over time, this can help the immune system become less reactive to the allergen, reducing allergy symptoms such as sneezing, runny nose, and itchy eyes. This mechanism is the basis for the subcutaneous immunotherapy (SCIT) being tested in the clinical trial. The product is classified in the therapeutic area of immune system diseases (ATC category C20).
Which conditions is it studied for?
- Allergic rhinoconjunctivitis to Dermatophagoides pteronyssinus and Dermatophagoides farinae — a condition with inflammation of the nose and eyes triggered by house dust mite allergens, causing sneezing, runny nose, nasal congestion, and itchy, watery eyes. The trial includes patients with moderate to severe persistent symptoms, with or without controlled asthma.
How is it given?
The product is a suspension for injection, given by the subcutaneous route (under the skin). Two strengths are being tested: Depigoid Mite-Mix at 50 DPP/ml and Depigoid FORTE Mite-Mix at 150 DPP/ml, each administered as a 0.5 ml injection. The trial also uses a placebo injection for comparison. In addition to the subcutaneous injections, the trial protocol includes several other medications used as background treatment or rescue therapy, including inhaled corticosteroids, antihistamines, leukotriene receptor antagonists, and bronchodilators.
What do the clinical trials show?
One trial is registered for this substance in the EU Clinical Trials Information System. It is a Phase 3, interventional study with a planned enrollment of 410 participants. The trial is currently authorised, meaning it has received regulatory approval to proceed but has not yet reported results.
What is the trial measuring?
The primary outcome is the change in the combined symptom and medication score (cSMS) from baseline to the timepoint after 12 subcutaneous immunotherapy (SCIT) doses have been administered. The cSMS combines the severity of allergy symptoms and the amount of medication needed to control them into a single score. Data are collected via an electronic diary installed on the patient's mobile device.
Who can take part?
The trial enrolls patients with moderate to severe persistent allergic rhinoconjunctivitis caused by Dermatophagoides pteronyssinus and Dermatophagoides farinae, with or without controlled asthma. The trial compares both strengths of the active product against placebo individually.
What side effects are known?
According to a US product label for a related house dust mite allergenic extract, severe systemic reactions may occur with allergenic extracts, and in certain individuals, especially those with steroid-dependent asthma, these reactions may be life-threatening or cause death. Patients are observed for at least 20 minutes following treatment, and emergency measures should be immediately available. The label also warns that patients receiving beta-blocking drugs may not respond to the usual dose of epinephrine if it is needed to control an adverse allergic reaction. The product should never be injected intravenously. This information comes from a US product label for a house dust mite injection and may not be specific to the investigational Depigoid product, but it illustrates the class of side effects associated with allergen immunotherapy.