Positive Phase III top-line results for somatrogon

C0311002, a Phase III, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with growth hormone deficiency (GHD), met its primary endpoint of improved treatment burden compared to Genotropin (somatropin) for injection administered once-daily, US pharma giant Pfizer (NYSE: PFE) and partner OPKO Health (Nasdaq: OPK) have reported.

Shares of OPKO, which received an upfront $295 million on signing the collaboration and is eligible for milestones, closed up 3.9% on Thursday and rose a further 2.2% to $4.67 in after-hours trading. Pfizer’s shares also gained 1.1%.

Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). The point estimate of the treatment difference was -15.49 (-19.71, -11.27 (95% CI); p<0.0001) in favor of somatrogon at the nominal 0.05 level. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen.