French biotech Lovaltech announced that the Agence nationale de sécurité du médicament (ANSM) and the Comité de Protection des Personnes (CPP) have authorized the company’s planned MUCOBOOST Phase 1 trial of LVT-001 nasal vaccine against COVID-19, and the trial is expected to start by the end of April 2025. The study, which is expected to enroll 36 adults aged 18-55, will evaluate 3 dose levels of LVT-001.
Lovaltech and its co-sponsors, the University of Tours regional hospital center and Inserm’s Emerging Infectious Diseases agency, expect to initiate a Phase 2 trial of the vaccine in early 2026, the company said. That trial is expected to enroll 202 subjects.
According to the Lovaltech web site, the company was formed in 2022 to develop the nasal vaccine technology, which was originally a collaboration between the University of Tours and the French National Research Institute for Agriculture, Food, and Environment (INRAE). The company says that it partnered with Aptar Pharma on development of the delivery device, and the site reports, “Aptar Pharma has committed to developing a dedicated production line for this device for LoValTech’s vaccines in France as part of the #France2030 project call, of which Lovaltech is a winner.”
Read the Lovaltech press release