Phase III C0311002 study of Somatrogon shows efficacy in growth hormone deficiency.- Pfizer + OPKO Health

Pfizer Inc and OPKO Health announced that 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. 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. no serious adverse events (saes) were reported during either of the treatment periods, and one participant discontinued use of somatrogon following a nonserious treatment-emergent adverse event (ae). the incidence of treatment-emergent aes between the treatment arms were comparable and all aes were mild to moderate in severity.>