Liver Therapy Forum weekly digest provides an overview on what’s happening in the NASH ecosystem in Q1/2019.
Due to the significant interest in liver therapeutics-focused investment opportunities, I highlight anticipated catalytic events that could increase or decrease stock value in Q1/2019.
Currently, over 30 drug candidates are in different phases of clinical trials for NASH.
This weekly newsletter provides news-related events with a focus on FDA, clinical trials and financials on stocks focused on the development of liver therapeutics.
Clinical Trials
NASH is a progressive chronic liver disease with many causal pathogenic factors. We have learnt from research that dysregulation of the glucose and lipid metabolic pathways could be associated with the development of NASH. Inflammation and activation of the apoptotic (i.e. cell death) machinery have both been reported to promote the development of NASH. NASH is often labeled a ‘silent disease’ because it is asymptomatic. Internally, the effects of NASH in the body is not a silent effect, with its pathogenic effects in the liver now being increasingly recognized: steatosis (i.e. fatty liver), inflammation, fibrosis and cirrhosis, all characteristic of NASH.
Regardless of the causal pathogenic factor(s), NASH is a 2-phase disease, early and late phase, with great unmet needs. In the absence of FDA-approved therapeutics, the prevalence of NAFLD, the precursor for NASH, and NASH are both expected to increase dramatically in the USA and globally in 2019 and beyond. Unfortunately, beginning 2020, NASH is expected to surpass HCV infection as the main cause of liver transplant. With over 30 drug candidates in clinical development for early phase or late phase NASH, a lot catalytic events are expected in Q1/2019 and beyond.
Top Line Data Readout
In Q1/2019, top line data readouts are expected from two Phase 3 anti-NASH drug candidates, selonsertib by Gilead (NASDAQ:GILD) and obeticholic acid by Intercept (NASDAQ:ICPT). Regardless of your investment preference, clinical history would be made in the NASH world. I also know some of you may agree with me that these are major catalytic events that could be a HUGE upside or downside for both companies. I have updated my thesis on these drug candidates in the liver therapy forum and would not discuss clinical expectations in this digest.
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