Researchers are planning a new study to evaluate the safety, tolerability, and pharmacokinetics of sotatercept as a treatment for children with pulmonary arterial hypertension (PAH).

The phase 2 study from Merck Sharp and Dohme will enroll up to 42 pediatric participants and is expected to start recruiting November 18, 2022. The estimated trial completion date is September 21, 2028.

Eligible children will be aged 1 to 17 years, diagnosed with PAH and World Health Organization Group 1, and on current standard care. Participants will receive sotatercept at a dosage of 0.3 mg/kg subcutaneously every 3 weeks for 24 weeks.


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There are 12 primary outcome measures of the new trial, comprising serum concentrations of sotatercept, adverse events, blood pressure, antidrug antibody levels, and a series of hematologic laboratory parameters. Eleven secondary outcome measures represent mean change from baseline in a variety of cardiac, pulmonary, and exercise parameters, functional class, and quality of life measurements.

Read more about PAH therapies

Sotatercept is an activin receptor type IIA-Fc fusion protein that can restore the balance between growth-promoting and growth-restricting signaling pathways in PAH. It selectively binds activins and growth differentiation factors, which can improve cardiopulmonary function in these patients. Sotatercept is not yet approved for use in any country, but it has been granted Breakthrough Therapy Designation by the US Food and Drug Administration and is currently in phase 2 and 3 studies.

PAH is a progressive type of pulmonary hypertension characterized by thickening and narrowing of the pulmonary arteries, leading to restricted pulmonary blood flow. The restricted blood flow leads to increased arterial pressure, which over time can lead to right ventricular heart failure and death if untreated.

Reference

Study to evaluate sotatercept (MK-7962) in children with pulmonary arterial hypertension (PAH) (MK-7962-008). ClinicalTrials.gov. October 20, 2022. Accessed November 2, 2022.