BNT331 / BioNTech - LARVOL DELTA

A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis (clinicaltrials.gov) - P1 | N=102 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

Trial completion • Vaginitis

Endolysin selectively kills Gardnerella ex vivo in vaginal samples from women with bacterial vaginosis. (PubMed, NPJ Biofilms Microbiomes) - "Endolysin treatment effectively disrupted Gardnerella biofilms and reduced viable bacterial load in a time- and concentration-dependent manner. These results informed the definition of the treatment dose for a first-in-human trial with BNT331-EL."

Journal • Preclinical • Vaginitis

A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis (clinicaltrials.gov) - P1 | N=102 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Enrollment closed • Vaginitis

A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Vaginitis

A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: BioNTech SE

New P1 trial • Vaginitis