Delving into the Latest Updates on Bacterial Lysates ( OM Pharma) with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms

Broncho-Vaxom, 泛福舒

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases+ [2]

Active Indication

Recurrent respiratory tract infectionsLower Respiratory Tract InfectionsAllergic asthma+ [1]

Inactive Indication

Alzheimer DiseaseCOVID-19Moderate Atopic Dermatitis

Originator Organization

OM Pharma SA

Active Organization

OM Pharma SA

Inactive Organization

Universitätsspital Basel

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 2015),

Recurrent respiratory tract infections

Regulation-

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People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community. Products obtained from dead bacteria ("bacterial lysate") can be used to boost immune system and may reduce the risk of respiratory infections. Very little information is available on the effect of these substances in older people. This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes. The study will include a treatment arm, in which participants will received the lysate, and a control arm in which participants will received a matching placebo (i.e., a pill that has the same appearance of the lysate but does not contain the lysate itself).

Start Date01 Feb 2025

Sponsor / Collaborator

Università Campus Bio-Medico di Roma

[+1]

NCT06486662

/ CompletedPhase 1

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

This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients

Start Date14 Jun 2024

Sponsor / Collaborator

OM Pharma SA

NCT05857930

/ RecruitingPhase 2

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo Given in Children Aged 6 Months to 5 Years With Recurrent Wheezing

This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing

Start Date20 Jun 2023

Sponsor / Collaborator

OM Pharma SA

100 Clinical Results associated with Bacterial Lysates ( OM Pharma)

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100 Translational Medicine associated with Bacterial Lysates ( OM Pharma)

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100 Patents (Medical) associated with Bacterial Lysates ( OM Pharma)

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176

Literatures (Medical) associated with Bacterial Lysates ( OM Pharma)

01 Dec 2024·Biomedicine & Pharmacotherapy

OM-85 attenuates high-fat diet-induced obesity, insulin resistance, gut dysbiosis and nonalcoholic steatohepatitis in a murine model

Article

Author: Hewady, Sarah ; Pasquali, Christian ; Manuel, Clarence R ; Reznik, Sandra E ; Koya, Jagadish

BACKGROUNDObesity is a global epidemic that is tied to a wide range of human disorders. Chronic consumption of a high-fat diet is linked to disruption of the intestinal microbiome, which drives obesity-related pathophysiology. Broncho-Vaxom® (OM-85), a bacterial lysate used for prophylaxis of recurrent respiratory tract infections, has both immunostimulatory and immunomodulatory functions.METHODSMale C57Bl/6 mice were maintained on normal control vs. high-fat diets for 8 weeks and treated or untreated with OM-85 or with the probiotic Lactobacillus plantarum, as a positive control. Mice were evaluated for weight gain, glucose tolerance, insulin tolerance, gut microbiome composition and non-alcoholic steatohepatitis (NASH).RESULTSHigh-fat diet mice developed obesity, insulin resistance, NASH and gut dysbiosis with a shift from the Bacteroidetes phylum, such as Bacteroidales order and Muribaculaceae family organisms to Firmicutes groups, such as the Clostridium and Blautia genuses. Treatment with OM-85 led to 1) prevention of obesity, 2) prevention of insulin resistance, 3) attenuation of NASH and 4) attenuation of gut dysbiosis, with decreased levels of the organisms mentioned above and increases in Verrucomicrobiae phylum organisms such as Akkermansia family microbes as well as Muribaculaceae organisms. These shifts in the gut microbiome predict favorable effects on the short chain fatty acid profile in the gut and increased integrity of the intestinal barrier. Pathway analysis showed that OM-85 decreases rates of carbohydrate metabolism, providing an additional mechanism whereby OM-85 prevents obesity.CONCLUSIONImmune modulators such as OM-85 should be investigated for their potential therapeutic effects on metabolism.

25 Jul 2024·Journal of Leukocyte Biology

Administration of a bacterial lysate to the airway compartment is sufficient to inhibit allergen-induced lung eosinophilia in germ-free mice

Article

Author: O’Connell, Kathryn ; Ezeh, Peace C ; Hahn, Seongmin ; Michael, Ashley N ; Banskar, Sunil ; Vercelli, Donata ; DeVries, Avery ; Pivniouk, Vadim ; Pivniouk, Oksana

AbstractThe nexus between eosinophils and microbes is attracting increasing attention. We previously showed that airway administration of sterile microbial products contained in dust collected from traditional dairy farms virtually abrogated bronchoalveolar lavage (BAL) eosinophilia and other cardinal asthma phenotypes in allergen-sensitized specific pathogen–free (SPF) mice. Interestingly, comparable inhibition of allergen-induced BAL eosinophilia and promotion of airway barrier integrity were found upon administration of a sterile, pharmacological-grade bacterial lysate, OM-85, to the airway compartment of allergen-sensitized SPF mice. Here, we asked whether intrinsic properties of airway-delivered microbial products were sufficient to inhibit allergic lung inflammation or whether these effects were mediated by reprogramming of the host microbiota. We compared germ-free (GF) mice and offspring of GF mice associated with healthy mouse gut microbiota and maintained under SPF conditions for multiple generations (Ex-GF mice). These mice were treated intranasally with OM-85 and evaluated in the ovalbumin and Alternaria models of allergic asthma focusing primarily on BAL eosinophilia. Levels of allergen-induced BAL eosinophilia were comparable in GF and conventionalized Ex-GF mice. Airway administration of the OM-85 bacterial lysate was sufficient to inhibit allergen-induced lung eosinophilia in both Ex-GF and GF mice, suggesting that host microbiota are not required for the protective effects of bacterial products in these models and local airway exposure to microbial products is an effective source of protection. OM-85–dependent inhibition of BAL eosinophilia in GF mice was accompanied by suppression of lung type 2 cytokines and eosinophil-attracting chemokines, suggesting that OM-85 may work at least by decreasing eosinophil lung recruitment.

01 Jul 2024·Pediatric Allergy and Immunology

A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis

Article

Author: Castro‐Rodriguez, Jose A. ; Turi, Kedir N. ; Forno, Erick

AbstractAcute respiratory tract infections (RTIs) are one of the most common causes of pediatric consultations/hospitalizations and a major trigger for asthma exacerbations. Some consensus statements have recommended the use of immunostimulants to boost natural defenses against severe or repeated infections. One of the most common immunostimulants is OM‐85; while several randomized clinical trials (RCTs) have evaluated its efficacy in preventing acute RTIs and wheezing/asthma exacerbations, results have been conflicting. Similarly, various systematic reviews with meta‐analyses (SRMs) on OM‐85 have used different strategies, populations, and outcomes; moreover, SRM conclusions are limited when the original studies are highly heterogeneous or have a low quality, hindering the generalizability of the findings. Here we summarize the evidence on the effect of OM‐85 to prevent acute RTIs, wheezing/asthma episodes, or loss of asthma control in children, by including and critically evaluating all SRMs published to date. We searched for SRMs on OM‐85 in three publication databases and found nine SRMs (seven for RTI, and two for wheezing/asthma). Among those, one had a high confidence evaluation of quality (AMSTAR‐2 tool) and found a reduction in the total number of acute RTIs among the OM‐85 group. Overall, no strong recommendations can be derived from the existing literature, mainly due to the high heterogeneity among included RCTs and SRMs. Further, large, high‐quality RCTs are needed to confirm the true efficacy of OM‐85 for the prevention of acute RTIs, asthma development, and asthma exacerbations.

100 Deals associated with Bacterial Lysates ( OM Pharma)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent respiratory tract infections	Switzerland	OM Pharma SA	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	France	OM Pharma SA	20 Dec 2021
Alzheimer Disease	Phase 3	Germany	OM Pharma SA	20 Dec 2021
Alzheimer Disease	Phase 3	Poland	OM Pharma SA	20 Dec 2021
Alzheimer Disease	Phase 3	Netherlands	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 3	Germany	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 3	France	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 3	Netherlands	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 3	Poland	OM Pharma SA	20 Dec 2021
Lower Respiratory Tract Infections	Phase 2	United States	OM Pharma SA	20 Jun 2023
Lower Respiratory Tract Infections	Phase 2	Hungary	OM Pharma SA	20 Jun 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01968421 (CTgov)	Phase 4	Bronchiectasis	196	OM-85 BV (OM-85)	ofqjvtrbbi(tyrbamqrdy) = hlyatroest aaiqkbaohp (yqxfkkjltr, rudqwjxfah - qonkffikdn) View more	-	21 Apr 2020
				OM-85 BV (Placebo)	ofqjvtrbbi(tyrbamqrdy) = bterjkqutl aaiqkbaohp (yqxfkkjltr, gvjilmblwy - odvgghjghf) View more
AAAAI2011	Not Applicable	Dermatitis, Atopic paternal atopy	553	Bacterial lysate	sveruugcus(pmvqppivup) = goazndbkfp vzazjktpyh (wkcmzhohjt )	Negative	01 Feb 2011
				Bacterial Lysate (Placebo)	sveruugcus(pmvqppivup) = pzbtgyfsae vzazjktpyh (wkcmzhohjt )