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-

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

CN (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 Nov 2024

Sponsor / Collaborator

Università Campus Bio-Medico di Roma

[+1]

NCT06486662 / RecruitingPhase 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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154

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

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

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

Review

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.

01 Jul 2024·Food Science and Technology International

Green alternative for sodium metabisulfite substitution: Comparison of bacterial and fungal proteases effect in hard biscuit making

Article

Author: Saberi, Farzad ; Kouhsari, Fatemeh ; Gasparre, Nicola

Sodium metabisulfite is one of the most employed reducing agents in hard biscuit making. The recent results about its adverse effects on human health have pushed us to look in new safer and greener directions. Two different proteases, from distinct strains (bacterial and fungal), were selected and their effects on the dough thermomechanical performances, texture, and structure of the hard biscuits were compared with those obtained from the sodium metabisulfite. Doughs treated with fungal protease showed higher stability during mixing and higher consistency throughout the heating stage. On the other hand, bacterial protease had the greatest weakening effect on protein with a marked reduction of starch gelatinization. Doughs processed with fungal enzymes reached similar values to those containing sodium metabisulfite. In terms of hardness, no significant ( p < 0.05) differences were found between biscuits made with bacterial protease and sodium metabisulfite. Analysis of the volumetric characteristics highlighted that bacterial enzymes gave higher values of specific volume and surface area. Regarding the structure of the hard biscuits, sodium metabisulfite produced a more uniform structure with fewer and smaller pockets as compared with the samples treated with proteases.

100 Deals associated with Bacterial Lysates ( OM Pharma)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AX	-

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Phase 2	HU	OM Pharma SA	20 Jun 2023
Lower Respiratory Tract Infections	Phase 2	PL	OM Pharma SA	20 Jun 2023
Alzheimer Disease	Phase 2	PL	OM Pharma SA	20 Dec 2021
Alzheimer Disease	Phase 2	DE	OM Pharma SA	20 Dec 2021
Alzheimer Disease	Phase 2	FR	OM Pharma SA	20 Dec 2021
Alzheimer Disease	Phase 2	NL	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 2	PL	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 2	DE	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 2	NL	OM Pharma SA	20 Dec 2021
Moderate Atopic Dermatitis	Phase 2	FR	OM Pharma SA	20 Dec 2021

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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)	sbinuwalue(wheinxbrtt) = mhildaujnw qbpdyknzos (dpesioidfg, obuamxggjf - gkmpuktrlc) View more	-	21 Apr 2020
				OM-85 BV (Placebo)	sbinuwalue(wheinxbrtt) = zhiiwlchjn qbpdyknzos (dpesioidfg, whgweelqhd - prctnnkdvi) View more
AAAAI2011	Not Applicable	Dermatitis, Atopic paternal atopy	553	Bacterial lysate	(ruiuinabir) = aofkcxfvri jjskqizjjr (trpvhbwfnk )	Negative	01 Feb 2011
				Bacterial Lysate	(ruiuinabir) = lnknqchals jjskqizjjr (trpvhbwfnk )