Update on Enobia Pharma's effort to develop ENB-0040 for treating HPP patients

Enobia Pharma today provided an update on key developments in its comprehensive effort to develop ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy, for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

Enobia announced today that it has been issued United States Patent No. 7,763,712 B2, providing robust intellectual property coverage for targeting alkaline phosphatase to bone. Coverage also extends to methods used to treat hypophosphatasia. The patent is projected to be in force until 2026.

Enobia was also awarded the Henning Anderson Prize for best clinical abstract from the European Society for Paediatric Endocrinology (ESPE).  The company will present new data from ongoing Phase 2 clinical studies of ENB-0040 in juveniles with HPP on September 24 at ESPE's Annual Meeting in Prague, Czech Republic.  Data will also be presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Toronto (October 16). These data build on positive preliminary findings presented in June at the 92nd Annual Meeting of The Endocrine Society (ENDO).

In addition, researchers will present new data from Enobia's Phase 2 trials of ENB-0040 in infants at the American Society of Human Genetics (ASHG) in Washington, DC (November 3). These data build on positive results presented at the ASBMR meeting in 2009, which demonstrated that in the majority of patients, six months of treatment with ENB-0040 led to marked improvements in bone mineralization, correction of skeletal defects, better respiratory function, and improvements in motor development.

Enobia also announced that the first patient has been dosed in its adolescent and adult HPP study. This 6-month study in 18 patients will compare the safety and efficacy of two different doses of ENB-0040 to an observational control group.

"We continue to advance all aspects of our clinical development program, and remain intensely focused on strong execution as we work to bring ENB-0040 to HPP patients of all ages as rapidly as possible," Robert Heft, PhD, President and CEO of Enobia. "We are very encouraged by the results we have seen to date in our ongoing Phase 2 clinical trials, and look forward to sharing these with the clinical community in the coming months."

SOURCE Enobia Pharma Inc.


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