Drugs / Broncho-Vaxom
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05222516 | Dec 2021 → Jul 2023 | atopic eczema | OM Pharma SA | Terminated | No outcome recorded |
| Phase 2 | NCT04129931 | Dec 2019 → Feb 2025 | asthma | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT03047954 | Jul 2003 → Dec 2006 | atopic eczema | Vifor Pharma | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05044169 | Sep 2021 → Sep 2023 | nephrotic syndrome of childhood - steroid sensitive | Fang Deng | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT05063149 Comparator | Mar 2022 → Dec 2029 expected | lower respiratory tract disorder | Franciscus Gasthuis | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | OM Pharma SA | Results Results of the ORBEX study ompharma.com ↗
The study did not demonstrate efficacy in preventing the onset of asthma or wheezing in the population evaluated. |
| 2026-06-14 | OM Pharma SA | Results OM Pharma Unveils the Largest Multi-Country Real-World Evidence Study on Broncho Vaxom® (OM 85) for RTI Prevention at EAACI 2026 ompharma.com ↗
REACH study met its first primary endpoint, showing that Broncho‑Vaxom® (OM‑85) was associated with a 28-38% reduction in respiratory tract infection rates at 12 months and 29-41% reduction at 24 months, comparing post-treatment versus pre-treatment initiation.1 |
| 2022-12-14 | OM Pharma SA | Regulatory OM Pharma successfully submitted an IND application to the FDA ompharma.com ↗
OM Pharma announced today that the U.S. Food and Drug Administration (FDA) has cleared its IND application for the phase IIb clinical study, a randomised placebo-controlled, double-blind, multicenter study to assess the efficacy and safety of OM-85 versus placebo given on top of routine treatment in children aged from 6 months to 5 years with recurrent wheezing episodes randomised. |
| 2022-07-27 | OM Pharma SA | Results In-silico identification of predictive biomarkers of response of OM-85 bacterial extract in Atopic Dermatitis ompharma.com ↗
A subset of immunological predictive biomarkers of response to OM-85 was identified within the in-silico framework, and the selection of virtual patients based on this subset of markers led to a better simulated efficacy. |
| 2021-12-01 | OM Pharma SA | Results The bacterial extract OM-85 reduces the binding of SARS-CoV-2 on human bronchial epithelial cells ompharma.com ↗
OM-85 significantly reduced the expression of ACE2 (p<0.001), DPP4 (p<0.005), TMPRSS2 (p<0.001) and cellular HS (p<0.01). |
| 2021-11-15 | OM Pharma SA | Results The bacterial extract OM-85 trains innate immune system and decreases betacoronavirus viral load in an in-vivo model ompharma.com ↗
Viral load and apoptosis of lung tissue was significantly reduced in the OM-85 pretreated group compared to the control group. |
| 2021-11-01 | OM Pharma SA | Results The bacterial extract OM-85 is decreasing in vitro SARS-CoV-2 viral infection in epithelial cells ompharma.com ↗
OM-85 strongly inhibits the binding of the SARS-CoV-2 spike protein to epithelial cells, resulting in a decreased SARS-CoV-2 infection in-vitro in the tested cell lines. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Broncho-Vaxom | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05063149 ↗ |
| Modality | Other / unclassified | “BV is an orally administered immunostimulating preparation, which consists of a lyophilised bacterial extract” NCT03047954 ↗ |
| Route | Oral | “BV is an orally administered immunostimulating preparation” NCT03047954 ↗ |