Dermatophagoides farinae enriched allergoid, mannan-conjugated, polymerised

Table of contents

• What is this substance?
• How does it work?
• Which conditions is it being studied for?
• How is it given?
• What do the clinical trials show?
• What side effects are known?

What is this substance?

Dermatophagoides farinae enriched allergoid, mannan-conjugated, polymerised is an investigational immunotherapy for house dust mite allergy. The full registry name also includes Dermatophagoides pteronyssinus enriched allergoid, mannan-conjugated, polymerised, because the product combines allergoids from both common house dust mite species.^[2] In the trial records it appears under the product name "Mannan-conjugated allergoid (polymerized) Dermatophagoides pteronyssinus and Dermatophagoides farinae parenteral vaccine".^[2] It has no marketing authorisation in the product records, meaning it is still an investigational substance.^[2] The authorisation holder listed in the records is INMUNOTEK S.L.^[2]

How does it work?

This substance is a form of allergen immunotherapy, also called specific immunotherapy. It contains modified allergen proteins (allergoids) from house dust mites that are conjugated to mannan and polymerised. The aim of this approach is to train the immune system to tolerate the allergen, reducing allergic symptoms over time. The therapeutic area recorded in the CTIS product records is immune system diseases.^[2] The exact molecular mechanism is not further described in the available trial data.

Which conditions is it being studied for?

The clinical trials study this substance for one main condition:

• Moderate-to-severe allergic rhinitis/rhinoconjunctivitis — with or without mild-to-moderate controlled allergic asthma, in people allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.^[2][1]

How is it given?

The substance is a solution for injection given by the subcutaneous route.^[2] In the trials, the dose studied is 3,000 mTU/mL administered subcutaneously, compared to placebo.^[2] The pharmaceutical form is reported as a 0.5 mL parenteral vaccine.^[2]

What do the clinical trials show?

Two authorised Phase 3 trials are listed in the EU Clinical Trials Information System, each planning to enrol 250 participants.^[2][1] Both trials have the same design and objective: to evaluate the clinical efficacy and safety of EP-088_MM09 at 3,000 mTU/mL compared to placebo in participants aged 12 to 65 years with moderate-to-severe persistent rhinitis/rhinoconjunctivitis, with or without mild-to-moderate intermittent or persistent controlled asthma.^[2][1]

The primary outcome in both trials is the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS), measured by means of the subject's diary.^[2][1] This score combines how severe a person's allergy symptoms are and how much medication they need to use. The trials are currently authorised but no results are reported yet.

Who can take part in these trials? Participants must be aged 12 to 65 years and have moderate-to-severe persistent rhinitis/rhinoconjunctivitis, with or without controlled asthma, and be allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.^[2][1]

What side effects are known?

The available trial records do not report side effect data for this substance. As the trials are still ongoing and no results have been published in the registry, no side effect information is currently available from these sources.