Press release: ANSM authorization for the MUCOBOOST First in human, phase I & II clinical trial
A major regulatory milestone has been achieved for LVT-001 and the LVT-NEXUS platform.
A major regulatory milestone has been achieved for LVT-001 and the LVT-NEXUS platform.The French National Agency for Medicines and Health Products Safety (ANSM) and the Ethics Committee have approved MUCOBOOST, a Phase 1/2 clinical trial evaluating the use of LVT-001, our intranasal vaccine for preventing infection with SARS-CoV-2.
The LVT-NEXUS mucosal delivery platform is being tested for the first time in this "first-in-human" trial. The trial is co-sponsored by Tours University Hospital (CHRU) and the ANRS Emerging Infectious Diseases Unit.
Phase 1, a dose-escalation study, will include 36 healthy volunteers at the CIC at Tours University Hospital (CHRU) and at Cochin-Pasteur in Paris. Phase 2 will involve 202 volunteers across five centres in the I-Reivac network, with an mRNA vaccine as comparator.
Aptar Pharma will manufacture the nasal delivery devices.