Enobia Completes Target Enrollment in Clinical Trial for Infantile Hypoph... ( MONTREAL March 3 /- Enobia Pharma an ...)

Enobia Completes Target Enrollment in Clinical Trial for Infantile Hypophosphatasia

Date:3/3/2009

MONTREAL, March 3 /PRNewswire/ -- Enobia Pharma, an emerging Canadian biotech company focused on developing novel therapeutics for serious bone disorders, today announced completion of target enrollment in its pilot clinical trial in infants suffering from a severe form of hypophosphatasia. Enobia is investigating Enzyme Replacement Therapy (ERT) with ENB-0040 for the treatment of this rare and often crippling genetic bone disorder for which there is no approved treatment.

ENB-002-08 is an open-label, six month study evaluating safety, efficacy and pharmacokinetics of subcutaneous ENB-0040 in hypophosphatasia infants with severe rickets and respiratory compromise. Six severely affected infants from the EU, US and the Middle East will be treated at approved sites in the US, Canada, UK and the United Arab Emirates. Key efficacy outcomes include improvement in rickets and clinical manifestations of the disease. Results from the trial will be presented at the Endocrine Society meeting in June.

A Phase I study, which evaluated safety, tolerability and pharmacokinetics of ENB-0040 in adults with hypophosphatasia was completed in December of 2008. Results of that study will be presented at the American College of Medical Genetics in March.

"Everyone involved in the clinical program is extremely pleased with our progress," said Robert Heft, CEO of Enobia. "Since filing an IND only eight months ago, we have completed a Phase I study and enrolled this Phase I/II study in infants. We believe ENB-0040 will be shown to significantly improve the devastating skeletal manifestations of hypophosphatasia and may potentially be life-saving therapy for those suffering from the lethal form of the disease."

Additional trials are planned. If interested in learning more, contact '/>"/>

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Enobia Completes Target Enrollment in Clinical Trial for Infantile Hypoph...( MONTREAL March 3 /- Enobia Pharma an ...)