PepGen Inc. provided updates on its CONNECT clinical program, which is investigating PGN-EDO51 in Duchenne muscular dystrophy (DMD) patients. The company reported that dosing for one participant in the 10 mg/kg cohort of the CONNECT1 study was paused due to a reduction in his estimated glomerular filtration rate.
In addition to the pause in dosing, PepGen received communication from Health Canada requesting additional information to address safety concerns. This request was made before any further dose escalation or enrollment of additional participants at the current dose levels could proceed.
Regarding the CONNECT2 study, which previously received a clinical hold from the FDA, PepGen stated it is actively working with the FDA. The company is addressing the agency's questions concerning supportive data for the dosing levels planned for the patient population in that trial.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.