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Enobia Announces Positive Clinical Results With ENB-0040, a Bone Targeted Enzyme Replacement Therapy for Hypophosphatasia
Date:9/14/2009

tudy have opted to continue treatment under a long-term extension protocol, and we have amended the initial study to include an additional five patients. We will also begin enrollment of a Phase 2 study in children aged five to 12 years in the weeks ahead."

Study Design and Findings

The infant study was designed to assess the safety, tolerability and efficacy of ENB-0040 in infants with HPP. Subjects received an initial intravenous dose of ENB-0040, followed by subcutaneous injections three times weekly for six months.

Three severely affected infants and two young children completed six months of treatment. There were no deaths or drug-related serious adverse events. Subcutaneous dosing was well tolerated, and no anti-ENB-0040 antibodies were detected. At six months, four of five patients with severe rickets treated with ENB-0040 showed marked radiographic, respiratory and functional improvement, while the fifth and most severely affected showed functional improvement and changes in biochemical markers suggesting bone remineralization. Notably, no new fractures were reported.

About Hypophosphatasia

Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease. Affected individuals have low levels of the tissue non-specific form of alkaline phosphatase, an essential regulator of bone mineralization, leading to rickets in infants and children and osteomalacia ("soft bones" resulting from poor mineralization) in adults. Disease severity is inversely proportional to the age at symptom onset. Clinical severity ranges from the severe perinatal or infantile forms, with marked skeletal hypomineralization and respiratory compromise often causing death, to a persistent and debilitating osteomalacia in adults.

In the infantile form, infants may appear normal at birth but develop serious symptoms in the first six months of life. These can include failur
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SOURCE Enobia Pharma Inc.
Copyright©2009 PR Newswire.
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