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Edelife XLHED Clinical Trial

Now Enrolling Pregnant Women

X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), the most common form of ectodermal dysplasia, is caused by a broad spectrum of mutations in the ectodysplasin A1 (EDA-A1) gene. The main symp- toms of XLHED are hypo- or anhidrosis, oligo- or anodontia and hypotrichosis. Current treatment options are limited to managing disease symptoms and complications. Effective corrective treatment for XLHED remains a high unmet medical need.

Edelife is a clinical study of the safety and possible health benefits of an investigational medicine for pregnant women expecting an ectodermal dysplasia (XLHED) affected boy.

Investigational Protein Intended to Replace EDA-A1 in utero

The Edelife investigational treatment, ER004, consists of a signaling protein replacement molecule designed for specific, high affinity binding to the endogenous receptor, intended to replace missing EDA-A1 protein in utero for patients with XLHED.

Administration at several specific points in pregnancy is essential, as ER004 impacts development of ectodermal precursors of sweat glands, teeth, etc.

EDA-A1 is missing in XLHED

illustration showing ER004 as an intended replacement for EDA-A1

ER004 as an intended replacement for EDA-A1

illustration showing ER004 as an intended replacement for EDA-A1

Compassionate Use of ER004 in XLHED Patients


Early referral is essential, as screening for Edelife must occur between weeks 19-24 of pregnancy. Contact an Edelife clinical site to refer a patient or request more information.
References: 1. Schneider H, Faschingbauer F, Schuepbach-Mallepell S, Körber I, Wohlfart S, Dick A, Wahlbuhl M, Kowalczyk-Quintas C, Vigolo M, Kirby N, Tannert C, Rompel O, Rascher W, Beckmann MW, Schneider P. Prenatal Correction of X-Linked Hypohidrotic Ecto- dermal Dysplasia. N Engl J Med. 2018 Apr 26;378(17):1604-1610. 2. Schneider, H.; Schweikl, C.; Faschingbauer, F.; Hadj-Rabia, S.; Schnei- der, P. A Causal Treatment for X-Linked Hypohidrotic Ectodermal Dysplasia: Long-Term Results of Short-Term Perinatal Ectodysplasin A1 Replacement. Int. J. Mol. Sci. 2023, 24,7155