Germany’s Paul-Ehrlich Institut has signed off on a Phase 1/2 clinical trial evaluating BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine program, BNT192, for the prevention of the respiratory infection, the first such study there.
The dose escalation portion will enroll ~200 subjects aimed at determining the optimal dose for further studies and assessing initial safety and immunogenicity. The trial will also evaluate the effects of repeat immunization for three of the four vaccine candidates that use uRNA or modRNA. Patients with higher risk of developing severe COVID-19 infection will be included in the second part.
A U.S.-based trial should launch shortly.
Pfizer (NYSE:PFE) is the company’s development partner.
BNTX will host a conference call tomorrow, April 23, at 8: 00 am ET to discuss the study.
BNTX is up 50% premarket and PFE is up 6%, both on modest volume.
