PepGen gets Health Canada nod to start trial of PGN-EDO51 for DMD
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- PepGen (NASDAQ:PEPG) said it received a no objection letter from Health Canada for an application to start a phase 2 trial of PGN-EDO51 in patients with Duchenne muscular dystrophy (DMD) amenable to an exon 51 skipping approach.
- The company expects to start dosing patients in H2 2023 and initial data readout in mid-2024.
- PepGen plans to evaluate PGN-EDO51 in about 3 groups of ambulatory and non-ambulatory boys and young men in the phase 2 study called CONNECT1-EDO51.
- "Building upon the encouraging safety, tolerability, and exon skipping data from our Phase 1 healthy volunteer (HV) study reported last year showing promising tolerability and exon-skipping activity, we are pleased to continue our work with the DMD community to develop a therapy that we hope will produce meaningful levels of a functional, skipped dystrophin protein," said PepGen's President and CEO James McArthur.
- DMD is a genetic disorder characterized by progressive muscle degeneration and weakness because of changes in a protein called dystrophin.