First drug approval in NASH

NASH TherapeutAix

When we reviewed the R&D landscape in nonalcoholic steatohepatitis (NASH) in 2018, we highlighted 4 development programs that were in Phase 3 development and all targeting pivotal data readout, and a potential launch, between 2019 and 2021. However, obeticholic acid, elafibranor, cenicriviroc, and selonsertib all turned out to not confirm their initial positive data in […]

International NASH Day 2022 – Enabling therapies for patients

International NASH Day 2022

Non-alcoholic steatohepatitis, or NASH, remains a disease with no approved therapeutics. And it’s been a tough area for drug development, with numerous Phase 2b and Phase 3 failures in the last few years. As a result, the landscape of active development projects has changed quite a bit from the time our review on NASH was […]

NASH – Challenges for drug development

It’s International NASH Day – and it’s also a while since we have last discussed NASH on the blog. In fact, even more has changed from the time when our review on NASH was published in 2019 – all 4 Phase III programs that were ongoing at that time (for obeticholic acid, elafibranor, cenicriviroc, and […]

International NASH Day 2019

On International NASH Day 2019 we discuss the mixed outcomes of NASH drug clinical trials and how we believe a platform of evidence can be built to support future NASH drug development. NASH (Nonalcoholic steatohepatitis) is emerging as a major public health issue for the 21st century that affects 7-12% of adults worldwide. It is […]

Recent study highlights the challenges in developing treatments for NASH

We previously commented on the failure of the ASK-1 inhibitor, selonsertib, in the STELLAR-4 phase III study in patients with compensated cirrhosis (F4) due to NASH. Selonsertib has been tested in another study (STELLAR-3) in an earlier stage (F3) of NASH, where it has now been announced that also here, selonsertib failed to meet the primary endpoint of […]

TherapeutAix NASH review article is now available online!

At the end of last year, TherapeutAix published an article titled ‘The future R&D landscape in non-alcoholic steatohepatitis’ in Drug Discovery Today. The review aims to give drug discovery teams guidance on navigating the maze of information currently available on NASH and to provide pointers on areas to consider in early research projects. The final […]

Navigating the NASH Maze

The availability of 2 approved medicines for the treatment of idiopathic pulmonary fibrosis (IPF) has stimulated an explosion in fibrosis research and in the search for new anti-fibrotic agents. Nowhere is this more evident than in the field of non-alcoholic steatohepatitis (NASH). While there have been multiple review articles covering NASH of late, TherapeutAix is […]

2022: A TherapeutAix Roundup

As the year draws to a close, we wanted to take a look back at our activities throughout 2022, reflecting on the return of in-person events, the advancements in medicine and the successes of our client projects. Here are our top highlights:    Events 2022 saw a welcomed return to in-person events, and we had […]

Reflections from ECM2022, Copenhagen, July 2022

The Extracellular Matrix Pharmacology Symposium 2022, aka ECM2022, took place in Copenhagen a couple of weeks ago. The focus of this three-day meeting was very much on the role of collagens and other extra-cellular matrix components in health and disease. What did we learn?   A lot about the basic structure and function of matrix proteins, […]

Christmas 2020 roundup from the TherapeutAix team

As 2020 draws to a close, the team at TheraeutAix has been looking back and reflecting on the last 12 months. Here’s a recap. A pandemic that changed a lot Let’s start with the obvious. The coronavirus pandemic challenged how we engaged with colleagues, conferences and in networking. We enjoyed our only in person meeting […]

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