OSE Immunotherapeutics today announced a voluntary and temporary pause of enrollment and dosing in its ongoing Phase 1 clinical trial for CoVepiT, the company’s investigational prophylactic COVID-19 vaccine candidate.
OSE Immunotherapeutics notified the Belgian Health Authorities that the Company is voluntarily pausing its Phase 1 clinical study of CoVepiT in healthy volunteers. This pause was decided after receiving a preliminary update by the trial’s principal investigator at the Center for Vaccinology, Ghent University, regarding a limited number of Grade 1 and one Grade 2 adverse events, in particular, persistent nodules around injection points (subcutaneous, with no pain, no inflammation, no fever, no impact on everyday life and without any systemic symptoms). Out of an abundance of caution, and in agreement with the independent Safety Monitoring Committee (SMC), the Company has decided to voluntarily pause dosing in its ongoing clinical study and assess the evolution of these nodules before determining the best way forward for this product and its target population. The Company will carefully review all available data to determine the future clinical development strategy of CoVepiT.
“As always, patient safety and wellbeing is our utmost priority, and we are working to resolve this unfortunate trial delay,” stated Alexis Peyroles, CEO of OSE Immunotherapeutics. “We will maintain an open dialogue with the SMC and with the trial’s principal investigator at the University of Ghent on the modalities to resume the clinical development of CoVepiT. In an ever-changing COVID-19 vaccine environment, where multiple lines of defences could be useful, in particular, for populations at higher risk, we believe it is valuable to have a candidate targeting 11 viral proteins and designed to cover all initial and new emerging SARS-CoV-2 variants.”