Inflammatory Bowel Disease

Monoclonal antibody
#Bionyra Pharma #Inflammatory Bowel Disease #Monoclonal antibodies #Phase I trial

Positive Phase I results for long-acting anti-TL1A antibody

Bionyra Pharma has announced positive interim results from its ongoing Phase I first-in-human study of BYN-002 (TL-001), a long-acting anti-TL1A monoclonal antibody that is in development to treat inflammatory bowel disease (IBD) and other TL1A-driven diseases.   The data are being presented in a late-breaking poster at United… Read More

#News

Crohn's disease
#Amorphical #Crohn's disease #Inflammatory Bowel Disease #Phase II trial

Novel non-immunosuppressive approach for Crohn’s

Amorphical has announced positive final long-term follow-up data from its Phase II clinical trial evaluating its investigational nano-amorphous Calcium Carbonate (ACC) therapy, for the treatment of moderate-to-severe Crohn’s disease.  The full data analysis, including a cohort of patients who completed follow-up extending up to 48 weeks post-baseline,… Read More

#News

ulcerative colitis
#Crohn's disease #Inflammatory Bowel Disease #NHS Scotland #Ulcerative colitis (UC)

Inflammatory bowel disease drug approved for use in NHS Scotland 

The Scottish Medicines Consortium (SMC) has accepted Tremfya (guselkumab) for use in NHS Scotland for the treatment of adult patients with moderately to severe Crohn’s disease and ulcerative colitis.  Guselkumab is the first IL-23 inhibitor that could offer a fully subcutaneous induction and maintenance regimen in Crohn’s disease and ulcerative… Read More

#News #Regulatory

Monoclonal antibody
#Crohn's disease #European Commission #Inflammatory Bowel Disease #Johnson & Johnson #Monoclonal antibodies

New EU approval for Johnson & Johnson’s guselkumab

The European Commission (EC) has approved Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for adult patients with moderately to severely active Crohn’s disease.  The approval is based on data which showed that guselkumab induction therapy administered either intravenously (GALAXI 2 and… Read More

#News #Regulatory

#Crohn's disease #Gastrointestinal #Inflammatory Bowel Disease #Phase I trial #Redx Pharma

Phase I data supports pan-ROCK inhibitor for Crohn’s disease

Redx Pharma has shared additional results from an RXC008 Phase I clinical trial at Digestive Disease Week 2025, San Diego, CA.  RXC008 is a highly potent pan-Rho-associated coiled-coil kinase (pan-ROCK) inhibitor that was designed to be restricted to the gastrointestinal (GI) tract.   The Phase I… Read More

#News

RNA
#Collaboration #Inflammatory Bowel Disease #PacBio #RNA sequencing #Wellcome Sanger Institute

RNA mapping project focuses on inflammatory bowel disease

Scientists at the Wellcome Sanger Institute in collaboration with Pacific Biosciences (PacBio) have launched a new initiative to map how gene activity shapes the immune system.  It is hoped that the project will identify new therapeutic targets for conditions such as inflammatory bowel disease (IBD). … Read More

#News

Monoclonal antibodies
#Inflammatory Bowel Disease #Monoclonal antibodies #Phase II trial #Sanofi #Teva

New data indicate duvakitug could “transform” IBD treatment

Sanofi and Teva Pharmaceuticals have revealed new results from their Phase IIb study of duvakitug for ulcerative colitis (UC) and Crohn’s disease (CD), the two most common forms of inflammatory bowel disease (IBD).   The results were shared in two oral presentations at the 20th Congress of the… Read More

#News #Trending News

#Biologics #GlobalData #Inflammatory Bowel Disease #Market reporting #Small molecules

Biologics for bowel disease face threat from cheaper small molecules

The total sales of inflammatory bowel disease (IBD) drugs are estimated to reach approximately $10.2 billion in the US in 2023, according to analysts. The increase in IBD biologic treatments has been a major driving force in the growth of this market in recent years. In 2007, AbbVie’s Humira received… Read More

#Market Reports #News

#Artificial intelligence (AI) #Generative AI #Inflammatory Bowel Disease #Insilico Medicine #Phase I trial

AI-designed PHD 1/2 inhibitor for bowel disease enters human trials

Insilico Medicine has initiated the first-in-human study for ISM5411, a poly hydroxylase domain (PHD) 1/2 inhibitor for the treatment of inflammatory bowel disease (IBD) designed by its generative AI platform. The company also plans to conduct global, multicentre Phase Ib trials in patients with ulcerative colitis… Read More

#News

Large intestine
#Francis Crick Institute #Genetics / genomics #Inflammatory Bowel Disease #King's College London #T cell activation

Specialised T cells could offer way to repair the gut barrier

Researchers from the Francis Crick Institute, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust in the UK have characterised a specialised type of immune cell, which plays a key role in protecting and repairing the cells in the healthy human gut. The researchers… Read More

#Editor's Choice #News

Blood tests in laboratory
#Clinical trial #Direct Biologics #Inflammatory Bowel Disease #Phase I trial

First patient dosed in ulcerative colitis drug trial

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). Direct Biologics uses extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs) to address multiple disease indications. The trial is… Read More

#News

US Food and Drug Administration
#Biologics / Biotechnology #Celltrion #Crohn's disease #FDA #Inflammatory Bowel Disease #Phase III trial #United States

First subcutaneous formulation of infliximab submitted to FDA

Celltrion USA has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for CT-P13 SC for the treatment of inflammatory bowel disease (IBD).  The submission is based on results from the Phase III pivotal data that evaluated the efficacy and safety of… Read More

#News #Regulatory

#Biotechnology #Drug development #Inflammatory Bowel Disease #Precision medicine

The start-up changing the game for IBD 

Jenny Bailey, CEO of Ferryx tells Lu Rahman how its leading product FX856 came to life and how it’s a game-changer for inflammatory bowel disease since it can act during active inflammation.  Ferryx is an innovative bio-tech start-up. It is a University of Bristol spin-out with a focus on gut health and IBD in… Read More

#Editor's Choice #Exclusive Content #Intelligence #News #Opinion #Start-up Zone #Trends & Analysis

#Drug development #Inflammatory Bowel Disease #Microbiology #Microbiome

Funding for new microbiome marker to aid treatment of IBD

Genetic Analysis (GA) has announced that the Norwegian Research Council has approved its grant application of NOK 16 million (€1.6 million) for its project developing new innovative microbiome-based diagnostics to be used to aid selection and treatment of Inflammatory Bowel Disease (IBD) patients. In this project, GA will develop an… Read More

#News