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May 03, 2015 2:44 PM ET

Biotechnology

Company Overview of Edimer Pharmaceuticals Inc.

Company Overview

Edimer Pharmaceuticals Inc. develops and delivers solutions for the improvement in the health and quality of life to future generations living with X-linked hypohidrotic ectodermal dysplasia (XLHED). It offers EDI200, an ectodysplasin A replacement protein for the treatment of XLHED. The company was founded in 2009 and is based in Cambridge, Massachusetts.

1 Broadway

8th Floor

Cambridge, MA 02142

United States

Founded in 2009

Phone:

617-758-4300

Fax:

866-334-4240

Key Executives for Edimer Pharmaceuticals Inc.

Chief Executive Officer, President and Director
Age: 53
Senior Director of Clinical Research
Director of Clinical Operations
Scientific Advisor
Clinical Advisor
Compensation as of Fiscal Year 2014.

Edimer Pharmaceuticals Inc. Key Developments

Edimer Pharmaceuticals Announces Completion of Dosing of the First Subject in the Second Cohort of the Ongoing Phase 2 Clinical Trial

Edimer Pharmaceuticals 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. EDI200 replaces EDA-A1, the protein missing in XLHED and a key regulator of skin and tooth development. Following successful completion of a Phase 1 study of EDI200 in XLHED-affected adults, the Phase 2 clinical trial of EDI200 in XLHED-affected newborn male subjects is being conducted at several European and three U.S. medical centers. EDI200 dosing is initiated between the 2nd and 14(th) days of life, with each study subject receiving 2 doses per week for a total of 5 doses. Edimer expects the trial to be fully enrolled by the fourth quarter of 2014, with top-line data expected in the first half of 2015. If fully developed and approved, EDI200 will be the first protein therapeutic to provide a sustained correction of the symptoms of this disorder.

Edimer Pharmaceuticals Announces Enrollment and Completion of Dosing of the First XLHED-Affected Neonate in a Phase 2 Trial of EDI200

Edimer Pharmaceuticals announced the enrollment and completed dosing of the first XLHED-affected neonate in a Phase 2 trial of EDI200, the company's novel, proprietary, recombinant protein. 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. EDI200 replaces EDA-A1, the protein missing in XLHED and a key regulator of skin and tooth development. If fully developed and approved, EDI200 will be the first protein therapeutic to provide a sustained correction of the symptoms of this disorder. The Phase 2 clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of EDI200 in XLHED-affected male newborns in the first two weeks of life. EDI200 dosing will be initiated between the 2(nd) and 14(th) days of life, with each study subject receiving two doses per week for a total of five doses.

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