Entrada Therapeutics, Inc. (NASDAQ:TRDA) today announced that an independent Data Monitoring Committee (DMC), per study protocol, has reviewed all available safety and PK data from the eight participants enrolled in Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose (MAD) portion of ELEVATE-45-201. The DMC recommended initiation of the Cohort 2 dose at 10 mg/kg, a dose escalation from 5 mg/kg in Cohort 1. ELEVATE-45-201 is a Phase 1/2 MAD clinical study of ENTR-601-45 for the potential treatment of Duchenne muscular dystrophy (DMD) in participants with a confirmed mutation in the DMD gene amenable to exon 45 skipping.

"We are pleased that after reviewing Cohort 1 data from our ELEVATE-45-201 study, the independent Data Monitoring Committee supports the initiation of Cohort 2 dosing at the increased dose of 10 mg/kg," said Natarajan Sethuraman, PhD, President of Research and Development at Entrada Therapeutics. "We look forward to sharing safety and early PK and dystrophin data from Cohort 1 of our ELEVATE-45-201 study in mid-2026. Importantly, with a dosing regimen of once every six weeks, ENTR-601-45 has the added potential to improve outcomes while decreasing the burden of treatment for people living with DMD who are exon 45 skipping amenable."