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Viking throws down gauntlet in NASH battle

Biotech is challenging rival Madrigal in 'next big thing' disease area


Impressive data in a phase 2 trial caused shares in Viking Therapeutics to almost double yesterday as investors got excited about another candidate for non-alcoholic steatohepatitis (NASH).

The condition is a hot target in pharma development at the moment, with a host of companies vying to bring forward new treatments for a disease viewed as an emerging health crisis – and an untapped pharma market. The build-up of liver fat can lead to fibrosis, cirrhosis and - in some patients - the need for a liver transplant.

Viking’s VK2809 – a thyroid hormone receptor beta agonist – was able to cut fat in the liver by 57%-60% on average compared to a 9% drop for placebo after 12 weeks’ treatment, tackling one of the main biomarkers for NASH and other forms of non-alcoholic fatty liver disease (NAFLD), and also reduced LDL cholesterol.

Moreover, 78%-91% of patients on the drug achieved the 30% or more reduction in liver fat deemed to be clinically significant, on that basis multiple analysts gave Viking’s drug a mid-stage victory over what has been seen as a frontrunner until now - a rival THR beta agonist in development at Madrigal Pharmaceuticals. In May, Madrigal reported its own phase 2 results with MGL-3196 in patients with biopsy-proven NASH, and also saw its share price surge as a result.

Analyst Andy Hsieh of William Blair said Madrigal’s drug showed an average 36%-42% reduction in liver fat overall, compared to 10% with placebo, with 60%-75% of patients on MGL-3196 hitting the 30% reduction threshold.

“Overall, given the strong efficacy data combined with benign safety profile, we believe the data could elevate VK2809 as the best-in-class thyroid hormone receptor beta agonist,” said Hsieh. Meanwhile, Raymond James analyst Steve Seedhouse has suggested the only advantage left to Madrigal at this point is that it is closer to starting a phase 3 programme.

The caveat of course is that the two trials have different enrolment criteria and patient baseline characteristics – in fact Madrigal’s trial was much bigger with around 150 patients versus Viking’s 45 – and history informs that there can be sizeable changes between phase 2 and 3 results with any experimental drug.

Rates of NASH are in the increase thanks to the rising incidence of obesity and diabetes, which increase the risk of developing the disease. Improvements in the treatment of viral hepatitis means NASH is now expected to be the leading cause of liver transplants by 2020, and some predictions suggest the market could quickly go from a standing start to reach $20bn to $35bn within the next few years.

Viking’s chief executive Brian Lian said that VK2809's effect on liver fat at 12 weeks “appears to exceed all other oral agents currently in development for NASH, supporting our view that VK2809 has a best-in-class profile.”

The company has submitted the data for presentation at the annual American Association for the Study of Liver Diseases (AASLD) taking place 9-13 November in San Francisco.

Shares in the San Diego-based company closed up 87% yesterday, having been up more than 140% in intraday trading.

Article by
Phil Taylor

19th September 2018

From: Marketing



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