Lonza signs manufacturing deal with Enobia
Contract covers the production of bone-targeted enzyme ENB-0040
Canadian firm Enobia has selected Lonza for the production of its bone-targeted enzyme replacement therapy ENB-0040 (asfotase alfa), under investigation for the treatment of hypophosphatasia (HPP).
Lonza will provide process validation and commercial manufacturing at its large-scale biologics site in Portsmouth, NH, US, with an option to extend production to a second Lonza site.
HPP is caused by a deficiency in the tissue non-specific form of alkaline phosphatase (TNSALP), an enzyme that plays a key role in regulating bone mineralisation.
Montreal-based Enobia recently completed a Phase II juvenile study of ENB-0040, which met the primary endpoint, demonstrating a statistically significant improvement in rickets when compared with historical matched cohort controls. Rickets, a softening and weakening of the bones, is often seen in children with HPP and can lead to fractures, pain and deformity.
The company previously reported the successful completion of an earlier trial in infants. Participants continue to demonstrate functional and respiratory improvements in longer-term follow-up. A Phase II study in adolescents and adults with HPP is ongoing.
