Edimer Pharmaceuticals’ EDI200 Expands To Higher Dose Cohort In Phase 2 Trial Following Positive Review Of Safety Data
5/28/2014 10:02:44 AM
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Edimer Pharmaceuticals, a biotechnology company focused on developing an innovative therapy for the rare genetic disorder, X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), today announced completion of dosing of the first subject in the second cohort of the ongoing Phase 2 clinical trial. Newborns in cohort 2 are administered the company’s proprietary ectodysplasin replacement protein EDI200 at the dose (10 mg/kg) that was found to maximize response and health benefits in the preclinical model of XLHED. Prior to cohort 2 initiation, the independent Data Safety Monitoring Board (DSMB) reviewed safety data from cohort 1 neonates dosed at 3 mg/kg and approved the dose escalation. XLHED is an ultra-rare orphan disease of ectoderm development associated with a lack of sweat glands, poor temperature control, respiratory problems, and hair and tooth malformations. Affected individuals are at risk for serious and potentially life-threatening hyperthermia and respiratory infections.
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