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Pfizer reports encouraging results for growth hormone deficiency trial
Pfizer Inc. (PFE) announced positive topline data from Phase 3 trial of its long-acting human growth hormone. The study involved patients between the age of 3 years and 18 years with growth hormone deficiency. The company’s drug candidate somatrogon is designed to be dosed once in a week.
The data showed that somatrogon succeeded in improving the mean overall Life Interference total score after 12 weeks of treatment compared to treatment with somatropin given once-daily. The primary endpoint of the trial pertained to the improvement in treatment burden by the drug candidate. Brenda Cooperstone of Pfizer said, “Patients and their loved ones have endured the burden of daily growth hormone injections for nearly 40 years, and we are working to improve this current standard of care with a long-acting, weekly option for the growth hormone disorders community.” The point estimate of the treatment difference was reported to be -15.49 in favor of somatrogon at the nominal 0.05 level.
The data also shed light on key secondary endpoints of the study. There was an overall improvement in treatment experience with the drug candidate administered in accordance with the protocol compared to the somatropin given once-daily. There were no reports of any serious adverse event during either of the treatment periods. However, one participant had to discontinue the use of somatrogon on account of a nonserious treatment-emergent adverse event. All the adverse events were found to be mild to moderate in their severity level.
Pfizer is collaborating with OPKO Health Inc. (OPK) for developing this drug candidate. The collaboration was formed in 2014 and focuses on developing and commercializing somatrogon for the treatment of GHD. The collaboration put the onus of conducting the clinical program on OPKO. Pfizer has been entrusted with the task of registering and commercializing the product. The companies also have the option to assess the potential for additional pediatric and adult indications, as deemed suitable.
C0311002 is a Phase 3, randomized, multicenter, open-label, crossover study. The primary endpoint of the study assessed the treatment burden of a somatrogon once-weekly injection schedule and a somatropin once-daily injection schedule. It used the difference in mean overall Life Interference total scores after each 12-week treatment schedule experience for this purpose.
Somatrogon is a novel molecular entity. It comprises the natural sequence of growth hormone. It also contains one copy of the C-terminal peptide from the beta chain of human chorionic hCG at the N-terminus and two copies at the C-terminus. These CTPs are helpful in extending the half-life of the molecule. The drug candidate was granted Orphan Drug designation in the US by the FDA. It has been granted the similar title in the European Union as well for treating children and adults with growth hormone deficiency.
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