BNT331 for Bacterial Vaginosis

No longer recruiting at 6 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: BioNTech SE

Must not be taking: Antifungals, Antimicrobials, Vaginal hormones

Disqualifiers: Pregnancy, Genital lesions, Drug abuse, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new treatment, BNT331, for bacterial vaginosis (BV), a common vaginal infection. The study consists of two parts: one for healthy women to test safety and another for women with BV to evaluate the treatment's effectiveness. Eligible participants include women with BV symptoms, such as unusual vaginal discharge, who have not recently used certain medications. This trial will help researchers determine if BNT331 is safe and effective for treating BV. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants will be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have received antifungal or antimicrobial therapy within 14 days before the first visit. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that BNT331 is likely to be safe for humans?

Research shows that BNT331 is undergoing its first human testing to assess safety. In this early stage, the main goal is to determine how well participants tolerate the treatment. As this is an initial trial, detailed safety information from human studies is not yet available. However, the trial is designed to closely monitor any potential side effects.

In lab tests, BNT331 has shown promise in targeting the bacteria responsible for bacterial vaginosis, but human trials are necessary to confirm its safety. Participants in this trial will contribute to gathering this crucial safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for BV?

Unlike the standard treatments for bacterial vaginosis, which typically involve antibiotics like metronidazole or clindamycin, BNT331 is a novel therapy with a different approach. Researchers are excited about BNT331 because it uses a unique mechanism, potentially targeting the condition more directly and effectively. Additionally, BNT331 is being tested in various dosing strategies, including single ascending doses and fixed doses over consecutive days, which could offer more flexible treatment options compared to current therapies. This innovative approach could lead to quicker relief and reduced recurrence, making it a promising new option for patients.

What evidence suggests that BNT331 might be an effective treatment for bacterial vaginosis?

Research has shown that BNT331 may help treat bacterial vaginosis (BV). In lab studies, BNT331-endolysin (BNT331-EL) successfully killed Gardnerella, the main bacteria causing BV, in vaginal samples from women with the condition. This suggests that BNT331 could reduce the harmful bacteria linked to BV. Early results also indicate that combining oral and vaginal treatments might be more effective than using vaginal treatments alone. While more research is needed, these findings are promising for those seeking new BV treatments. Participants in this trial will receive either BNT331 or a placebo to further evaluate its effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

Part A of the trial is for healthy women, while Part B is for women with bacterial vaginosis. Participants must meet specific health criteria not detailed here.

Inclusion Criteria

I am not experiencing menstrual or vaginal bleeding.

Healthy according to screening procedures (Part A) or suffering from BV but otherwise healthy (Part B)

My condition has been stable before joining the trial.

Exclusion Criteria

I have had cancer in the past 5 years, including cervical, vaginal, or vulvar cancer.

Pregnant, lactating, or planning to become pregnant during their study participation and for specified days after visits

Participated in any investigational study within specified days before Visit 1 or currently participating/plans to participate in any investigational or observational study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose of BNT331 or placebo

1 day

1 visit (in-person)

Follow-up Part A

Participants are monitored for safety and adverse events after the single dose

12 days

Treatment Part B

Participants with bacterial vaginosis receive multiple ascending doses of BNT331 or placebo for 5 consecutive days

5 days

Self-administered at home

Follow-up Part B

Participants are monitored for safety, adverse events, and clinical outcomes after multiple doses

120 days

What Are the Treatments Tested in This Trial?

Interventions

• BNT331

Trial Overview The study tests BNT331 against a placebo in two parts: first to check safety in healthy women and then its effectiveness in those with bacterial vaginosis.

How Is the Trial Designed?

Group I: BNT331 - Part B Dose 2 Experimental Treatment 1 Intervention

Fixed dose for 5 consecutive days

Group II: BNT331 - Part B Dose 1 Experimental Treatment 1 Intervention

Fixed dose for 5 consecutive days

Group III: BNT331 - Part A Experimental Treatment 1 Intervention

Single ascending dose levels

Group IV: Placebo - Part B Placebo Group 1 Intervention

Multiple dose

Group V: Placebo - Part A Placebo Group 1 Intervention

Single dose

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Published Research Related to This Trial

In a study of 152 patients with bacterial vaginosis, both oral and vaginal treatments with ornidazole and oral secnidazole combined with vaginal metronidazole achieved a 100% cure rate, demonstrating their high efficacy.

The results suggest that using a combination of oral and vaginal medications is more effective than using vaginal treatments alone, indicating a potential strategy for improving treatment outcomes in bacterial vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of bacterial vaginosis with oral or vaginal ornidazole, secnidazole and metronidazole. Saraçoğlu, F., Göl, K., Sahin, I., et al.[2019]

High dose vaginal metronidazole therapy (HDM) provided short-term remission in 68% of patients with recurrent bacterial vaginosis (RBV) who did not respond to standard oral treatment, indicating its potential as an effective alternative.

Patients with higher diagnostic scores indicating prolonged dysbiosis were more likely to experience recurrence after HDM, suggesting that certain pre-treatment conditions may predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. Sobel, JD., Kaur, N., Woznicki, NA., et al.[2022]

Bacterial vaginosis is a prevalent condition that can lead to unpleasant vaginal discharge and is linked to increased risks of sexually transmitted infections and negative pregnancy outcomes.

This review highlights existing treatment options for bacterial vaginosis and discusses new therapies being developed to improve management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial treatment of bacterial vaginosis: current and emerging therapies. Menard, JP.[2021]

A 14-day treatment with metronidazole significantly improved cure rates for bacterial vaginosis (BV) compared to a 7-day treatment, although the benefits did not last beyond 21 days, indicating potential relapse or reinfection.

Adding azithromycin to the treatment regimen did not provide any additional benefit, while factors like lower baseline Nugent scores and practicing safe sex were associated with higher cure rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of the duration of therapy with metronidazole plus or minus azithromycin for treatment of symptomatic bacterial vaginosis. Schwebke, JR., Desmond, RA.[2013]

In a study involving 577 patients, a single dose of secnidazole (2 g) was found to be as effective as the standard multiple-dose metronidazole (500 mg twice daily for seven days) in treating bacterial vaginosis, with cure rates of 60.1% and 59.5% respectively.

Both treatments had comparable safety profiles, suggesting that secnidazole offers a convenient alternative for patients and clinicians in managing bacterial vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Bohbot, JM., Vicaut, E., Fagnen, D., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12344050/

Endolysin selectively kills Gardnerella ex vivo in vaginal ... This study evaluated the pharmacodynamics of BNT331-endolysin (BNT331-EL) on vaginal samples from 49 women with BV (Nugent score ≥7, Amsel ...

2. clinicaltrials.biontech.com clinicaltrials.biontech.com/trials/BNT331-01

A First‑in‑human Safety Trial of BNT331 Administered as ... This is a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy

3. withpower.com withpower.com/trial/phase-1-vaginosis-bacterial-6-2024-3dd8f

BNT331 for Bacterial Vaginosis · Info for Participants The results suggest that using a combination of oral and vaginal medications is more effective than using vaginal treatments alone, indicating a potential ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06469164?tab=history&a=2

Record History | NCT06469164 A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BNTX/pressreleases/34005093/biontech-ses-bnt331-safety-trial-a-potential-game-changer-in-womens-health/

BioNTech SE's BNT331 Safety Trial: A Potential Game- ... The study aimed to evaluate the safety, tolerability, and pharmacokinetics of BNT331, a vaginal insert, in healthy women and women diagnosed ...

6. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT06469164

NCT06469164 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 ...