On the heels of competitor Madrigal’s excellent trial results another small BioPharma company has released phase 2 results that sent their company stock skyrocketing. Galmed Pharmaceuticals, a small Israeli biopharmaceutical company, produced statistically significant results with a drug called Aramchol in the lowering of fat in the liver at 52 weeks. The analysis of the results was embraced by the markets, which sent the stock soaring 250%.
In one endpoint, more patients treated with 600 mg of Aramchol versus placebo achieved NASH resolution without worsening of fibrosis, at 16.7% versus 5.0% (p=0.0514), respectively, as well as NASH resolution more generally, at 19.2% compared to 7.5% (p=0.0462). In addition, the second biopsy endpoint showed a higher proportion of patients with at least a one-point improvement in fibrosis score without worsening of NASH.
We are at an exciting time for NASH treatment options with multiple companies pursuing promising candidates. People suffering from NASH will still require significant lifestyle changes but hearing about more successful trial results is a very positive step towards getting a grip on the pandemic.
Today I had the pleasure of meeting a fantastic group of medical professionals that are all working hard on solving the NASH pandemic as part of International NASH Day’s worldwide efforts to fight the disease. I’ll be blogging much more about what I learned and hopefully will be able to follow up with some interesting pieces from some of the great people I met today.
The terrific folks at The NASH Education Program have worked with providers and advocates across the industry to organize this worldwide day of action to raise awareness for NASH. They have asked me to tell my personal story to help provide the perspective of someone who has dealt with loss due to NASH.
I’m truly honored to be a part of this fantastic event. For full information see the PDF here.
Today was a much anticipated date in the search for the first medical treatment for NASH. Madrigal Pharmaceuticals, a Pennsylvania-based Bio-Pharma company, has been running clinical trials with its NASH candidate MGL-3196, and was due to announce the preliminary results of those trials.
From Medscape comes an informative article about the growing problem of NAFLD & NASH. The article presents the troubling projections in the growth of non-alcoholic liver diseases in the USA.
The current worldwide prevalence of NAFLD is approaching 25%. The prevalence of NAFLD in the United States is increasing, owing to a rising incidence of obesity and type 2 diabetes mellitus.[8,9] Current US projections indicate a 21% increase in NAFLD numbers, leading to a 33.5% overall prevalence by 2030. Coupled with a 63% increase in patients with nonalcoholic steatohepatitis (NASH), there will be a 168% increase in the number of patients with decompensated end-stage liver disease, and a 137% increase in the numbers of patients developing HCC from NAFLD. The growing numbers of NAFLD patients with hepatic fibrosis indicate that end-stage liver disease from NAFLD will probably become the most common reason for liver transplantation in the United States.
The rest of the article talks about and summarizes all of the useful information available, from lean NASH to treatment options, and includes updated guidance from AASLD (American Association for the Study of Liver Diseases).
While there is a clear causal relationship between obesity, NAFLD, and NASH, studies have shown that there are a significant number of cases of NASH affecting non-obese individuals. In a recent study up to 15% of those diagnosed with NASH were not considered obese. These cases are referred to as lean NASH or NOSH (non-obese steatohepatitis).
This is a fascinating article full of technical detail about an emerging alternative thesis explaining the progression from NAFLD to NASH. It also goes into detail about how biopharma company Gilead is pursuing multiple avenues and theories on NASH progression as part of a comprehensive plan to create a medical treatment for it. Continue reading “Lipotoxicity and NASH”→