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Microbiome Drug Articles & Analysis

33 news found

LISCure`s Phase 2 Drug Candidate Granted Orphan Drug Designation (ODD) from US FDA

LISCure`s Phase 2 Drug Candidate Granted Orphan Drug Designation (ODD) from US FDA

LB-P8, a novel drug being developed by LISCure Biosciences, Inc. (LISCure) as a treatment for Primary Sclerosing Cholangitis (PSC), has been designated as an orphan drug by the US FDA. On December 1, 2022, the US FDA notified LISCure of the orphan drug designation of LB-P8, LISCure's microbiome novel drug, as ...

ByLISCure Biosciences Inc.


Seres Therapeutics Presents Microbiome Therapeutic Research at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Seres Therapeutics Presents Microbiome Therapeutic Research at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Phase 3 ECOSPOR III Study of SER-109 Data Encore Cancer patients are at greater risk of developing rCDI and tend to have worse outcomes, due to their weakened immune system and frequent antibiotics exposure.i Encore data from the completed double-blind, randomized, placebo-controlled Phase 3 ECOSPOR III trial (NCT03183128) show that the investigational microbiome therapeutic ...

BySeres Therapeutics, Inc.


Annual General Meeting of Infant Bacterial Therapeutics

Annual General Meeting of Infant Bacterial Therapeutics

Infant Bacterial Therapeutics AB (publ) (IBT) is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the ...

ByInfant Bacterial Therapeutics AB


Seres Therapeutics Presents Phase III Results of SER-109 for Recurrent C. Difficile Infection at the Digestive Disease Week (DDW) Annual Meeting

Seres Therapeutics Presents Phase III Results of SER-109 for Recurrent C. Difficile Infection at the Digestive Disease Week (DDW) Annual Meeting

Food and Drug Administration (FDA) in mid-2022, positioning SER-109 up to potentially become the first ever FDA-approved microbiome-based therapeutic for treating recurrent C. difficile infections with a potential product launch in the first half of 2023. ...

BySeres Therapeutics, Inc.


Seres Therapeutics Presents Preclinical Research on Investigational Microbiome Therapeutic SER-155 at the 2022 European Bone Marrow Transplantation Annual Meeting

Seres Therapeutics Presents Preclinical Research on Investigational Microbiome Therapeutic SER-155 at the 2022 European Bone Marrow Transplantation Annual Meeting

According to published clinical data from Memorial Sloan Kettering, patients undergoing this type of transplant who have less diverse gut flora are significantly more likely than patients with a richer microbiome to experience infection or GvHD. The trial will help inform whether SER-155 can restore a healthy microbiome and support transplant recovery. About ...

BySeres Therapeutics, Inc.


Seres Therapeutics to Present Data on Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection at the Digestive Disease Week (DDW) Annual Meeting

Seres Therapeutics to Present Data on Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection at the Digestive Disease Week (DDW) Annual Meeting

Seres expects to finalize a Biologics License Application (BLA) submission for SER-109 with the U.S. Food and Drug Administration (FDA) in mid-2022. “We are eager to showcase new data that further validate the potential of our investigational microbiome therapeutic, SER-109, at the world’s largest gathering of physicians and researchers in the ...

BySeres Therapeutics, Inc.


Seres Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Updates

Seres Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Updates

--(BUSINESS WIRE)--May 4, 2022-- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported first quarter 2022 financial results and provided business updates. ...

BySeres Therapeutics, Inc.


Axial Therapeutics Announces Participation of its CEO, A. Stewart Campbell, in Longwood Healthcare Leaders Spring MIT Webconference

Axial Therapeutics Announces Participation of its CEO, A. Stewart Campbell, in Longwood Healthcare Leaders Spring MIT Webconference

The company is a scientific leader in the biological role of the microbiome-gut-brain axis and its influence on the central nervous system. Harnessing its unique expertise in the microbiome, Axial is developing small molecule drugs with defined mechanisms of action that act on new targets to mitigate the impact of metabolites and bacteria in the ...

ByAxial Therapeutics Inc.


Bio-Me Joins Microbiome Therapeutics Innovation Group

Bio-Me Joins Microbiome Therapeutics Innovation Group

The Microbiome Therapeutics Innovation Group (MTIG) today announced the addition of Bio-Me to its coalition of companies leading the research and development of FDA-approved microbiome therapeutic drugs and microbiome-based products. Bio-Me offers a wide range of proprietary solutions to facilitate the gut ...

ByBio-Me


Aptorum Group Limited Interview to Air on Bloomberg U.S. on the RedChip Money Report®

Aptorum Group Limited Interview to Air on Bloomberg U.S. on the RedChip Money Report®

The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases; and (ii) the co-development of a novel ...

ByAptorum Group Limited


Microviable will be attending Pharmabiotics Event 2022

Microviable will be attending Pharmabiotics Event 2022

The Pharmabiotics Conference brings together players from academia and industry and it is an incredible opportunity to meet stakeholders and discuss the further innovation in microbiome-based drug products and regulatory affairs. Reach out to us if you want to meet during the conference event or to receive any further information about Microviable. ...

ByMicroviable Therapeutics SL


Axial Therapeutics’ Scientific Founder Sarkis Mazmanian, Ph.D., to Present Research Highlighting the Gut-Brain Connection in Autism Spectrum Disorder (ASD) at TACA’s Autism Action Conference

Axial Therapeutics’ Scientific Founder Sarkis Mazmanian, Ph.D., to Present Research Highlighting the Gut-Brain Connection in Autism Spectrum Disorder (ASD) at TACA’s Autism Action Conference

About AB-2004 AB-2004 is a first-in-class, molecular therapeutic that targets the microbiome gut-brain axis and its role in co-occurring conditions associated with ASD. ...

ByAxial Therapeutics Inc.


Infant Bacterial Therapeutics publishes Annual Report for 2021

Infant Bacterial Therapeutics publishes Annual Report for 2021

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to ...

ByInfant Bacterial Therapeutics AB


Nature Medicine Publishes Full Results from Axial Therapeutics’ Phase 1b/2a Clinical Trial in Autism Spectrum Disorder (ASD)

Nature Medicine Publishes Full Results from Axial Therapeutics’ Phase 1b/2a Clinical Trial in Autism Spectrum Disorder (ASD)

“The data highlighted in Nature Medicine further support our novel therapeutic strategy focused on specific targets in the gut microbiome. We strongly believe that AB-2004 can improve the quality of life of many children with ...

ByAxial Therapeutics Inc.


New Preclinical Research Published in Nature Highlights an Active Role by Microbiome-Derived Metabolites in Brain Function and Anxiety-like Behavior

New Preclinical Research Published in Nature Highlights an Active Role by Microbiome-Derived Metabolites in Brain Function and Anxiety-like Behavior

“By starting to identify how bacterial metabolites in the gut can impact behavior, it offers a tremendous opportunity to discover and validate new drug targets in the gut microbiome that may lead to novel medical interventions for the treatment of neurological conditions that adversely affect quality of ...

ByAxial Therapeutics Inc.


Aurealis Therapeutics and Xbiome Enter into a License and Collaboration Agreement for Aurealis Four-in-One Diabetic Foot Ulcer and Inflammatory Disease Cell and Gene Therapy AUP-16 in Greater China

Aurealis Therapeutics and Xbiome Enter into a License and Collaboration Agreement for Aurealis Four-in-One Diabetic Foot Ulcer and Inflammatory Disease Cell and Gene Therapy AUP-16 in Greater China

Aurealis Therapeutics, a synthetic biology company developing groundbreaking four-in-one cell and gene therapies and Xbiome, an AI-based microbiome drug development company, today announced that the two companies have entered into an exclusive license and collaboration agreement for the clinical development and commercialization of Aurealis investigational ...

ByAurealis Therapeutics


Dr. Ryan Gordon joins the Stem Pharm team as Sr. V.P. of Business Development

Dr. Ryan Gordon joins the Stem Pharm team as Sr. V.P. of Business Development

He has been a valued leader at large companies (3M) and emerging startups (Rion, StemoniX, Rebiotix) where he made significant contributions to the pioneering development of regenerative exosome and microbiome therapeutics, 3D organoids for drug discovery, and novel drug delivery technologies. ...

ByStem Pharm, Inc


Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

Axial’s gut-targeted approach minimizes the potential for side effects due to a lack of systemic exposure to the drug. Axial is evaluating AB-2004 in a Phase 2b clinical trial based upon a large body of existing human safety data. ...

ByAxial Therapeutics Inc.


MV BioTherapeutics to present at the 6th Microbiome Movement - Drug Development Europe

MV BioTherapeutics to present at the 6th Microbiome Movement - Drug Development Europe

We are happy to announce that Fabio Grassi (MV BioTherapeutics founder) has been invited to contribute to the 6thMicrobiome Movement – Drug Development Summit Europe 2022 in London during January 25th-27th, 2022. The presentation has been included in stream A titled “Understanding mechanisms of action & preclinical development” the 26th at 13.45. Microbiota Adaptation ...

ByMV BioTherapeutics SA


Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder

Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder

Axial’s gut-targeted approach minimizes the potential for side effects due to a lack of systemic exposure to the drug. Axial is evaluating AB-2004 in a Phase 2b clinical trial based upon a large body of existing human safety data. ...

ByAxial Therapeutics Inc.

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