EDI-200
Also known as: anti-EDAR agonist antibody, APO200, ER004
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Summary
EDI-200 (also known as APO200 or ER004) is an investigational agonist monoclonal antibody targeting EDAR, developed primarily for the treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED), a rare genetic disorder caused by loss-of-function mutations in the EDA gene. Early intervention during fetal or neonatal life is critical as ectodermal structures must develop during a narrow developmental window. Clinical trials have evaluated prenatal and postnatal administration. It has received Orphan Drug and Breakthrough Therapy designations.
Mechanism of Action
EDI-200 is a fully human agonist monoclonal antibody that binds to and activates EDAR (ectodysplasin A receptor), mimicking the function of EDA-A1 (ectodysplasin-A isoform 1). This activation of the EDA/EDAR/NF-κB signaling pathway promotes the development of ectodermal appendages including sweat glands, teeth, and hair follicles during fetal and neonatal development.
Routes of Administration
Goals & Uses
- Treatment of XLHEDRare Genetic DiseaseModerate
- Restoration of sweat gland developmentRare Disease / Ectodermal DysplasiaModerate
- Improvement of dental and hair developmentRare Disease / Ectodermal DysplasiaLow
- Prevention of hyperthermia riskSymptom PreventionModerate
Contraindications
- Known hypersensitivity to EDI-200 or its componentsAllergy / ImmunologyHigh
- Infections not under adequate treatmentInfectious DiseaseModerate
Adverse Effects
- Transient laboratory abnormalitiesLaboratoryUncommon
- FeverSystemicUncommonElevated body temperature
- Potential immunogenicity (ADA formation)ImmunologicUnknown
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- ImmunosuppressantsModeratePotential interaction with immune pathways or infection risk
Population Constraints
- Pregnant women (fetal administration)PregnancyRelative
- Patients with active infectionsInfectious DiseaseRelative
- Pediatric neonatesAgeRelative
Regulatory Status
- European UnionInvestigationalOrphan Drug Designation granted by EMA for XLHED; not yet approved
- United StatesInvestigationalOrphan Drug Designation and Breakthrough Therapy Designation granted by FDA; not yet approved
Granted Orphan Drug Designation by the FDA and EMA for XLHED. Received Breakthrough Therapy Designation from the FDA. Not yet approved for marketing. Developed by Edimer Pharmaceuticals and later associated with Syndax/other sponsors.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is EDI-200?
EDI-200 (also known as APO200 or ER004) is an investigational agonist monoclonal antibody targeting EDAR, developed primarily for the treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED), a rare genetic disorder caused by loss-of-function mutations in the EDA gene. Early intervention during fetal or neonatal life is critical as ectodermal structures must develop during a narrow developmental window. Clinical trials have evaluated prenatal and postnatal administration. It has received Orphan Drug and Breakthrough Therapy designations.
What is EDI-200 used for?
EDI-200 is educationally associated with: Treatment of XLHED, Restoration of sweat gland development, Improvement of dental and hair development, Prevention of hyperthermia risk. Educational only — not medical advice.
How is EDI-200 administered?
Recorded routes of administration: Intra Amniotic (prenatal Investigational), Intravenous.
What are the potential side effects of EDI-200?
Reported adverse effects include: Transient laboratory abnormalities, Fever, Potential immunogenicity (ADA formation), Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid EDI-200?
Recorded contraindications: Known hypersensitivity to EDI-200 or its components, Infections not under adequate treatment. Consult a qualified clinician before use.