Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT331 · 1 trial · 1 indication
Treatment-emergent adverse events (TEAEs) are those Adverse Events with an onset on or after the date and time of study treatment or events which were present before treatment, and which worsened after treatment. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition.
Treatment-emergent adverse events are those AEs with an onset on or after the date and time of study treatment or events which were present before treatment, and which worsened after treatment. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition. AE were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE.
| Arm | Type | Description |
|---|---|---|
| Part A: Placebo (Combined for Cohorts 1, 2 and 3) | PLACEBO_COMPARATOR | Healthy participants received a single dose of placebo administered as a vaginal insert on Day 1. |
| Part A: Cohort 1: BNT331 2 Milligram (mg) | EXPERIMENTAL | Healthy participants received a single 2 mg dose of BNT331 administered as a vaginal insert on Day 1. |
| Part A: Cohort 2: BNT331 5 mg | EXPERIMENTAL | Healthy participants received a single 5 mg dose of BNT331 administered as a vaginal insert on Day 1. |
| Part A: Cohort 3: BNT331 20 mg | EXPERIMENTAL | Healthy participants received a single 20 mg dose of BNT331 administered as a vaginal insert on Day 1. |
| Part B: Placebo (Combined for Cohorts 4 and 5) | PLACEBO_COMPARATOR | Participants diagnosed with bacterial vaginosis received placebo as a vaginal insert once daily for five consecutive days. |
| Part B: Cohort 4: BNT331 5 mg | EXPERIMENTAL | .Participants diagnosed with bacterial vaginosis received 5 mg dose of BNT331 as a vaginal insert once daily for five consecutive days. |
| Part B: Cohort 5: BNT331 20 mg | EXPERIMENTAL | Participants diagnosed with bacterial vaginosis received 20 mg dose of BNT331 as a vaginal insert once daily for five consecutive days. |
| Name | Type | Description |
|---|---|---|
| BNT331 | DRUG | Vaginal insert |
| Placebo | OTHER | Vaginal insert |
Inclusion Criteria (applicable to all participants unless otherwise specified): * Had given written informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures. * Participant reported assigned female sex at birth, at least 18 years of ag...
BNT331 is an investigational small molecule being developed for the treatment of bacterial vaginosis, a common vaginal infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BNT331 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
BNT331 is in Phase 1 clinical development. A first-in-human trial has been completed, which evaluated single ascending doses in healthy women and multiple ascending doses in women diagnosed with bacterial vaginosis.
BNT331 has one completed Phase 1 clinical trial registered as NCT06469164. This trial enrolled 102 female participants in the United States and was a randomized, double-blind, placebo-controlled study assessing safety.
No alternative names for BNT331 have been reported. It is identified solely by its code name BNT331 in clinical trial registries and scientific literature.