Endpoint Selection Could Help Determine The NASH Race
Sponsors in the hotly pursued and yet untapped field of non-alcoholic steatohepatitis think that selection of different primary or co-primary endpoints could help differentiate their programs in the competitive space.
You may also be interested in...
Public Company Edition: Madrigal and Galmed shares more than doubled after reporting what were viewed as positive results in mid-stage NASH studies, with Madrigal going on to raise $300m on the back of the data. Not all is well for publicly traded firms, however, as Advaxis and Flex Pharma reveal layoffs.
Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.
The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.