Liver disease

Intercept Pharmaceuticals’ obeticholic acid (OCA) could be first drug to be approved in the US for non-alcoholic steatohepatitis (NASH), according to analysts GlobalData.  The Food and Drug Administration (FDA) accepted the company’s resubmission of its new drug application (NDA) for OCA in patients with pre-cirrhotic liver fibrosis due to NASH in December 2022.  According to […]

China is expected to record the highest diagnosed prevalence of non-alcoholic fatty liver disease (NAFLD) in 2029, representing 44% of cases within the 16 major pharmaceutical markets (16MM).   As a result, the number of clinical trials conducted in the country for this indication is gradually increasing, driven mostly by international pharmaceutical companies.  According to GlobalData’s […]

Enanta Pharmaceuticals, a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, has dosed the first subject in its Phase I clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV).  Context   RSV is the most common cause of bronchiolitis […]

News round-up for 10-14 October by DDW Digital Content Editor Diana Spencer The top news in the world of drug discovery this week reflects the vital importance of collaboration, partnership and support within this industry.  Partnerships have been forged and renewed to shed light on neuropsychiatric disorders, oncology and cystic fibrosis. Meanwhile, Ochre Bio successfully raised […]

Ochre Bio, a company developing therapies for liver health challenges, has closed $30 million in Series A financing, which will be used to translate the insights from their discovery research into RNA-based drug candidates, and then test these in human livers at their recently launched ‘Liver ICUs’ across the US.   Employing a deep phenotyping […]

MiNA Therapeutics has dosed the first patient in a global Phase II clinical trial (OUTREACH-2) of MTL-CEBPA in combination with second line standard of care sorafenib (a tyrosine kinase inhibitor (TKI)) in advanced hepatocellular carcinoma (HCC or liver cancer).  What is OUTREACH-2?  OUTREACH-2 is a multi-centre, open-label, randomised study of MTL-CEBPA in combination with sorafenib, compared to sorafenib […]

Dompé Farmaceutici has entered a strategic collaboration with and investment in Engitix as part of Engitix’s $54m Series A financing to support identification of new treatments against fibrosis and liver-associated solid tumours.  The agreement   Dompé will provide direct access to facilities, resources and expertise including its Exscalate structure-based drug design platform which can design new molecules following the rules of rational drug design to obtain […]

In a clinical trial, Mount Sinai scientists gave immunotherapy to liver cancer patients before they received surgery and found that tumours died off significantly before surgery in a third of the patients, according to results reported in The Lancet Gastroenterology and Hepatology.   The results  The researchers believe that the neoadjuvant immunotherapy—therapy given before surgery—not only may kill the tumour prior […]

Researchers at the Francis Crick Institute and Universidade de Santiago de Compostela have identified how the hepatitis B virus (HBV) can support the survival and growth of liver cancer, with this process starting early in tumour development, in some instances up to 20 years before cancer diagnosis.  Context  Around 240 million people around the world are infected with HBV. […]

More physiologically and pathologically relevant preclinical human liver models are needed for drug liver liability assessment and liver disease modeling. While Drug-Induced Liver Injury (DILI) remains a major safety concern, several recent high-profile NAFLD/NASH clinical trial failures further highlight this critically unmet need. With the advances in 3D culture, we and others have demonstrated the […]