End the Cycle: Discover a Targeted Fight Against BV Without Losing Your Microbial Allies!
Rundown on the Study
Bacterial vaginosis affects up to 30% of women worldwide, leading to discomfort and a higher risk of reproductive and infectious complications. Unfortunately, current treatments often fall short, with a high rate of recurrence. That’s where BNT331 comes in: a cutting-edge therapy targeting the root cause of BV with the potential to offer a more effective and resilient solution.
We’re excited to introduce the BNT331-01 trial, a pioneering Phase I study aimed at transforming the treatment of bacterial vaginosis (BV). This randomized, double-blind, placebo-controlled trial is designed to explore the safety, tolerability, and pharmacokinetics of BNT331, a novel treatment administered in single ascending doses to healthy women and multiple ascending doses to those diagnosed with BV.
What Makes BNT331 Special?
Targeted Action: BNT331 selectively combats Gardnerella spp., a primary culprit behind BV, without harming beneficial bacteria.
Innovative Approach: Leveraging a modified phage-derived endolysin, BNT331 aims to break through the biofilm barrier that shields harmful bacteria, a challenge that traditional antibiotics struggle to overcome.
Hope for Recurrent Sufferers: Especially designed for those suffering from recurrent or persistent BV, BNT331 represents a beacon of hope where other treatments may not have succeeded.
Who Can Participate?
We’re looking for women to join us on this journey! Check if you meet the criteria below:
Inclusion Criteria:
- Healthy women (for single ascending dose study)
- Women diagnosed with bacterial vaginosis (for multiple ascending dose study)
- Non-pregnant, non-breastfeeding, and pre-menopausal individuals
Exclusion Criteria:
- Known hypersensitivity to antibiotics
- Participation in another clinical trial within the last 30 days
- Any condition that, in the investigator’s opinion, could compromise the study’s integrity or participant’s safety