Opko Health Inc.'s phase 3 study of its investigational long-acting human growth hormone product, hGH-CTP, in adults with growth hormone deficiency did not achieve its primary endpoint.
The drug failed to show a statistical difference compared to placebo in changing the trunk fat mass from baseline to 26 weeks.
However, after unblinding the study, the company said it has identified one or more outliers that might have affected the primary outcome and plans to undertake a further review of the study population as soon as possible.
Opko has also initiated a phase 3 study in pre-pubertal growth hormone deficient children to evaluate weekly treatment with the drug versus daily injections of Genotropin.
The company has a worldwide collaboration and license agreement with Pfizer Inc. for the development and commercialization of hGH-CTP. Under the agreement, Opko is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.