Sanofi's (SNY) Nexviazyme met all primary and secondary endpoints as a potential treatment for infantile-onset Pompe disease in a phase 3 study, the company said.

Pompe disease is a rare ailment with symptoms that include skeletal muscle weakness causing mobility problems and impacting the respiratory system.

The drug met its primary endpoint of keeping patients alive and free of invasive ventilation in previously untreated infants at 52 weeks, the company said.

The study met all secondary endpoints, including proportion of participants alive and free of invasive ventilation at 12 and 18 months of age, and improvements in other measures of disease progression at 52 weeks, the company said.

Sanofi plans to submit the data to support a US regulatory application in H2 2026, the company said.