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更新于：2026-06-17
Bacterial Lysates ( OM Pharma)
细菌溶解产物
更新于：2026-06-17
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2015-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
28
项与 细菌溶解产物 相关的临床试验ChiCTR2600125322
A Multicenter, Open-label, Randomized Controlled Trial to Evaluate the Efficacy and Safety of OM-85 Combined with Subcutaneous Allergen Immunotherapy (SCIT) in Children with House Dust Mite–Induced Asthma in Southern China
NCT06655272
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
NCT06486662
Safety, Tolerability and Pharmacodynamics of Single and Multiple Ascending Doses of OM-85-IN Versus Placebo in Healthy Volunteers, and Patients With Mild Allergic Asthma Using Nasal Allergen Challenge
100 项与 细菌溶解产物 相关的临床结果
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100 项与 细菌溶解产物 相关的转化医学
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100 项与 细菌溶解产物 相关的专利（医药）
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165
项与 细菌溶解产物 相关的文献（医药）2026-03-01RESPIRATORY MEDICINE
The bacterial lysate OM-85 reduces exacerbations and oral corticosteroid use in frequently exacerbating patients with T2-High asthma: The OMREXA real-world evidence study
Article
作者: Panteli, Lilia S ; Moisidis, John Α ; Christopoulou, Maria Elpida ; Christopoulos I, Ioannis A ; Tryphonidou, Amalia S ; Christopoulos, Antonios I
BACKGROUND:
Underlying immune modifications are offered by the Polyvalent Chemical Bacterial Lysate OM-85 (i.e., anti-viral properties, enhancement of the epithelium barrier function, and induction of a tolerance landscape in the lungs). This secondary post hoc analysis used data from the OMRIA study, to assess the effect of add-on OM-85 on reducing the risk for exacerbations of any origin in adults with difficult-to-treat T2-high asthma.
METHODS:
The Oral Bacterial Lysate OM-85 Prevents Respiratory Tract Infections in Asthma (OMRIA) study enrolled adults with T2-high asthma frequently exacerbating, under standard of care asthma therapy (SoC), who were started on OM-85 (two 3-month courses with a 3-month treatment-off period in between). Patients were assigned to two groups (OM-85 plus SoC n = 70 and SoC group n = 67) and all AEXs and OCS bursts were recorded throughout a 12-month period. A clinical categorization to identify infectious and non-infectious AEXs was also applied: 1. Asthma symptoms alone (non-infectious), 2. Combined asthma and common cold symptoms (infectious), 3. Combined asthma and bronchitis, sinusitis, or pneumonia symptoms (infectious).
RESULTS:
The weighted with propensity scores analyses (Poisson and negative binomial regression model), verified the statistically significant decreases in the average numbers of AEXs and OCS bursts reported in OMRIA study, in patients treated with OM-85. Same tendencies were recorded in each AEX class (class 1-non-infectious: 50.5% decrease, classes 2 and 3-infectious: 72.2% and 89.8% decrease, respectively).
CONCLUSION:
This secondary post hoc analysis supports the therapeutic benefit of OM-85 in patients with T2-high asthma who have frequent exacerbations despite adherence to SoC asthma therapy.
2026-03-01ANTIVIRAL RESEARCH
Prophylactic intranasal administration of bacterial lysate OM-85 mitigates human rhinovirus (RV-A1b) lung infection and inflammation in mice
Article
作者: Pasquali, Christian ; Braun, Armin ; Obernolte, Helena ; Wronski, Sabine ; Baulier, Edouard ; Vaslin Chessex, Anne ; Sewald, Katherina ; Schaudien, Dirk
Rhinovirus (RV), a common cold virus, is a predominant circulating virus which is increasingly recognized for its contribution to severe respiratory tract infections. Given the lack of vaccines, bacterial lysates are a promising alternative to prevent recurrent respiratory tract infections. OM-85, a bacterial lysate from 21 respiratory bacteria, has long been used safely as an oral drug to prevent recurrent respiratory tract infections in clinics. However, with inhalation emerging as preferred route to directly target the site of airway infection, OM-85 is being developed for local administration in the respiratory tract to enhance mucosal immunity. This study evaluated the prophylactic efficacy of intranasally administered OM-85 in a murine model of RV infection. Mice were treated over a period of 12 days prior to RV infection and the immune response and viral load were assessed. Intranasal administration of OM-85 primed the host immune response by the recruitment of innate immune cells to the lung, resulting in enhanced viral clearance. This was accompanied by a modulation of the RV-induced immune response toward a less pro-inflammatory phenotype, marked by substantial reduction of pro-inflammatory cytokines and neutrophil infiltration. The immune response was shifted towards an anti-inflammatory state supporting control of inflammation. Complementary precision-cut lung slice experiments confirmed the initial immune-priming activity of OM-85 independent of RV infection. These findings demonstrate that local administration of OM-85 in the airways effectively primes the innate immune response and confers mucosal protective effects against RV-induced respiratory tract infection.
2026-02-01JOURNAL OF ASTHMA
Immunomodulatory effects of bacterial lysates on the IL-17 signaling pathway in an asthma mouse model
Article
作者: Wei, Xiaoying ; Li, Fang ; Yin, Li ; Wang, Xue ; Gao, Mimi
BACKGROUND:
Severe asthma is a clinically heterogeneous and often treatment-refractory condition, in which steroid resistance and persistent neutrophilic airway inflammation are frequently driven by the IL-17 signaling axis. However, upstream regulatory mechanisms and effective therapeutic interventions targeting this pathway remain poorly defined. This study aimed to investigate the immunomodulatory effects of OM-85, a bacterial lysate-based agent, and its regulatory role on IL-17-associated signaling in a murine model of allergic asthma.
METHODS:
An ovalbumin (OVA)-induced mouse model of asthma was used to evaluate the effects of OM-85. Airway hyperresponsiveness (AHR), histopathological changes, and cytokine profiles were assessed. Quantitative real-time PCR and western blotting were performed to evaluate inflammatory gene and protein expression. Transcriptomic enrichment and immunofluorescence co-localization analyses were conducted to validate OM-85's impact on the IL-17A/TRAF5/NF-κB signaling pathway.
RESULTS:
OM-85 administration significantly reduced AHR, goblet cell hyperplasia, and peribronchial collagen deposition in asthmatic mice. Expression of Th2 cytokines (IL-4, IL-5, and IL-13) was markedly suppressed, while IFN-γ levels were restored, indicating a rebalancing of Th1/Th2 responses. Bioinformatics analysis and experimental validation revealed that OM-85 downregulated the IL-17A/TRAF5/NF-κB axis. Immunofluorescence staining confirmed a reduction in IL-17A-Ly6G and IL-17A-TRAF5co-localization, suggesting disruption of IL-TRAF-mediated inflammatory circuits.
CONCLUSIONS:
OM-85 exerts multi-dimensional immunoregulatory effects in allergic asthma by suppressing IL-17A-mediated signaling and restoring immune homeostasis. These findings suggest that OM-85 may represent a promising immunotherapeutic approach for managing steroid-resistant asthma phenotypes associated with IL-17-driven inflammation.
100 项与 细菌溶解产物 相关的药物交易
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外链
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 反复呼吸道感染 | 中国 | 2015-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 下呼吸道感染 | 临床2期 | 美国 | 2023-06-20 | |
| 下呼吸道感染 | 临床2期 | 澳大利亚 | 2023-06-20 | |
| 下呼吸道感染 | 临床2期 | 匈牙利 | 2023-06-20 | |
| 下呼吸道感染 | 临床2期 | 波兰 | 2023-06-20 | |
| 中度特应性皮炎 | 临床2期 | 法国 | 2021-12-20 | |
| 中度特应性皮炎 | 临床2期 | 德国 | 2021-12-20 | |
| 中度特应性皮炎 | 临床2期 | 荷兰 | 2021-12-20 | |
| 中度特应性皮炎 | 临床2期 | 波兰 | 2021-12-20 | |
| 过敏性哮喘 | 临床1期 | 德国 | 2024-06-14 | |
| 特应性皮炎 | 临床阶段不明 | 瑞士 | - |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 196 | (OM-85) | 廠鹹製積觸壓鹹築網衊(繭膚積壓範憲鹽壓願網) = 憲憲觸構顧醖鬱獵艱膚 構積鏇蓋壓築觸鏇膚範 (窪夢鏇蓋餘醖齋鹽憲積, 1.19) 更多 | - | 2020-04-21 | ||
(Placebo) | 廠鹹製積觸壓鹹築網衊(繭膚積壓範憲鹽壓願網) = 築淵繭選夢構鏇獵壓窪 構積鏇蓋壓築觸鏇膚範 (窪夢鏇蓋餘醖齋鹽憲積, 0.98) 更多 | ||||||
N/A | 340 | 膚齋積艱窪壓鹹憲範構(壓網製鬱遞膚選齋夢顧) = 繭襯範選蓋繭範淵窪醖 艱蓋淵築淵襯壓窪遞糧 (憲鑰艱窪遞選鏇繭繭蓋 ) 更多 | 积极 | 2011-09-01 | |||
Placebo | 膚齋積艱窪壓鹹憲範構(壓網製鬱遞膚選齋夢顧) = 築糧觸鬱選窪鬱範遞製 艱蓋淵築淵襯壓窪遞糧 (憲鑰艱窪遞選鏇繭繭蓋 ) 更多 | ||||||
临床4期 | 80 | (Broncho-Vaxom Group) | 蓋衊鏇選築膚糧襯顧醖(網淵衊鏇壓鑰夢齋觸衊) = 衊鑰壓糧窪膚鏇鹹鏇壓 廠築鏇蓋窪襯夢醖簾範 (觸鏇積積糧夢網鑰鹹夢, 1.61) 更多 | - | 2010-08-16 | ||
Placebo (Placebo Group) | 蓋衊鏇選築膚糧襯顧醖(網淵衊鏇壓鑰夢齋觸衊) = 網遞蓋鬱襯蓋醖顧築糧 廠築鏇蓋窪襯夢醖簾範 (觸鏇積積糧夢網鑰鹹夢, 2.72) 更多 |
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