PepGen Announces Regulatory Updates on Freedom2 Trial

PepGen announced regulatory updates related to the Freedom2 trial. The U.S. Food and Drug Administration has placed a partial clinical hold on the Freedom2-DM1 Phase 2 multiple ascending dose, randomized, placebo-controlled clinical trial of PGN-EDODM1 in patients with myotonic dystrophy type 1. The partial clinical hold questions raised by FDA relate to previously submitted preclinical pharmacology and toxicology studies. The partial clinical hold did not cite any questions regarding blinded clinical data from the Phase 1 Freedom study previously submitted to the FDA in order to initiate the Freedom2 study in the U.S. As part of its ongoing dialogue with the FDA, the Company is submitting additional analyses, including the recently unblinded Freedom data, and is committed to working with the FDA to address their questions as quickly as possible. PepGen was recently cleared to open the Freedom2 study in New Zealand, Australia, and South Korea. The Company expects to report data from the 5 mg/kg cohort of Freedom2 in the first quarter of 2026, and from the 10 mg/kg cohort in the second half of 2026.