The FDA has placed a hold on BioNTech’s phase 1/2a trial, pausing the company’s efforts to develop a RNA-based vaccine for malaria prevention.
The hold includes BioNTech’s investigational new drug application and the related clinical trial assessing multi-antigen malaria vaccine BNT165e, according to a Securities and Exchange Commission (SEC) document filed March 4.
The Germany-based company said it is complying with the hold and working to address the next steps with the FDA, according to the SEC filing. Before this, BioNTech had proactively paused the study, the company said.
BioNTech declined further comment, pointing to the SEC filing as the company’s statement on the matter.
The paused study had been designed to assess BNT165e as a preventive treatment for Plasmodium falciparum malaria among healthy malaria-naïve adults. The two-part trial is expected to enroll a total of 177 participants, with a primary readout slated for September of this year, according to ClinicalTrials.gov.