Genflow Biosciences plc has received correspondence from Belgium’s Federal Agency for Medicines and Health Products (FAHMP) with a recommendation to initiate a phase I/II trial of GF-1002 in patients with nonalcoholic steatohepatitis (NASH), rather than in healthy volunteers.
Hepagene Therapeutics Inc. has received FDA clearance of its IND application for HPG-7233 for the treatment of patients with nonalcoholic steatohepatitis (NASH) and dyslipidemia.
In the gastrointestinal tract, intraepithelial lymphocytes are tasked with protecting the epithelium against pathogens and participating in wound repair and correct mucosal barrier functioning. In a study published in the Sept. 15, 2023, issue of Science, researchers at King’s College London and collaborators have identified a specific subset of gamma-delta (γδ) T cells in the human gut, Vγ4 cells, which seems to protect against inflammatory bowel disease (IBD) progression.
Positive phase III data from Cymabay Therapeutics Inc. with seladelpar, the peroxisome proliferator-activated receptor for primary biliary cholangitis (PBC), could mean trouble for Intercept Pharmaceuticals Inc.’s second-line therapy, the farnesoid X receptor agonist Ocaliva (obeticholic acid), which Cymabay aims to replace with its compound as the preferred choice.
Laborie Medical Technologies Inc. continued a string of recent deals with an agreement to acquire Urotronic Inc. for $255 million cash up front with an additional $345 million in payments contingent on meeting specified commercial and reimbursement milestones. Laborie already held a minority interest in the manufacturer of the Optilume drug-coated balloon technology for treatment of urethral strictures and benign prostatic hyperplasia (BPH).
Nexys Therapeutics Inc. has identified aryl hydrocarbon receptor (AhR) agonists and their prodrugs reported to be useful for the treatment of inflammatory bowel disease, multiple sclerosis and Huntington’s disease.
Phathom Pharmaceuticals Inc. made recent headway with its new mechanism of action in gastroesophageal reflux disease (GERD) even as further, disturbing discoveries in the space are seeing daylight. Florham Park, N.J.-based Phathom turned over to the U.S. FDA the requested six-month stability data related to reformulated vonoprazan tablets, and the numbers remained consistent with three-month data, reflecting N-nitroso-vonoprazan nitrosamine control and levels comfortably more than tenfold below the acceptable daily intake limit.
Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that occur after mild traumatic brain injury such as headaches, dizziness and problems with concentration and memory.
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