Newborn XLHED Clinical Trial:
Investigating a Potential Treatment for Children with XLHED
Status: Not enrolling participants
In the Newborn X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Clinical Trial, Edimer Pharmaceuticals evaluated whether EDI200, a recombinant protein, has any impact on the symptoms of children affected by XLHED, including the early development of teeth, sweat glands, hair follicles and more.
Ten babies participated. Edimer reviewed six-month data from all enrolled participants and data up to two years for the first participant who enrolled. Unfortunately, the clinical trial did not achieve its expected outcomes. There were some modest signs of improvement in biologic activity, meaning the development and function of various body parts that XLHED affects. However, they didn’t see significant changes in sweat gland function and other early markers of biologic activity at this time.Learn More
Status: Edimer closed its doors in 2016 and will not be continuing with any XLHED research.
Prof. Holm Schneider from Erlangen, Germany was one of the initial primary investigators in the clinical trial. He and other investigators have a strong feeling that dosing after birth is too late to impact the development of sweat glands and other key markers. They believe the dosing needs to occur by injecting EDI200 into the mother’s amniotic fluid, prior to birth.
In 2016, Prof. Schneider engaged in a “Trial to Cure” which is a legal possibility under the German law to dose. He administered EDI200 to a set of twin boys in utero who were affected by XLHED.Read how EDI200 impacted the twin boys.
Learn more about the history of XLHED research that the NFED has initiated and families have advanced.