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CymaBay Therapeutics plummets after abandoning NASH drug

Failure of mid-stage liver disease candidate caused shares to slip over 75%


CymaBay Therapeutics has abandoned its liver disease drug seladelpar, after planned biopsies identified a type of liver damage in some patients in the mid-stage study. 

The phase 2b study of seladelpar was being studied in patients with non-alcoholic steatohepatitis (NASH), and in a recently initiated phase 2 study in patients with primary biliary cholangitis (PBC).

NASH is characterised by a build-up of fat that can lead to fibrosis, cirrhosis and in some cases the need for a liver transplant. The incidence of NASH is growing globally due to an epidemic of obesity and diabetes, which increase the risk of developing the disease.

However planned, blinded histological assessments of the first group of liver biopsies revealed atypical findings. This included autoimmune hepatitis in the trial studying patients with NASH.

Worryingly, these abnormalities were observed in patients who had demonstrated improvement on the study or stabilization after 52 weeks of treatment.

Following the announcement, shares in CymaBay fell over 75% – seladelpar is the company’s main candidate, meaning its failure leaves little else in the pipeline other than pre-clinical or phase 1 studies.

“In light of the findings, we have decided to terminate our NASH and PSC studies and place our PBC studies on hold pending further review and follow-up. We are very disappointed in having to halt the development of seladelpar at this time but patient safety and care is paramount,” said Sujal Shah, CEO of CymaBay.

“We would like to thank patients and their families, as well as the investigators and site personnel that have participated in these studies,” he added.

A number of pharma companies are vying for the first-to-market place in NASH, but so far none have been successful.

This includes Gilead – its key phase 3 candidate selonsertib failed in a crucial phase 3 test back in April, after it failed to meet its primary endpoint to improve fibrosis without worsening of NASH in those with bridging fibrosis.

However, Gilead didn’t abandon the drug completely, as it highlighted a phase 2 ATLAS trial involving testing selonsertib in a regimen made up of cilofexor and firsocostat in patients with advanced fibrosis due to NASH.

German drugmaker Boehringer is also looking to enter the market, after it signed a $870m licence deal with South Korean biotech Yuhan in July to bolster its NASH pipeline. The deal will draw on Yuhan’s expertise in fibroblast growth fact 21 (FGF21) – a drug target for NASH and other liver diseases.

Other major pharma players looking to break into the NASH market first include Pfizer, Novartis, Allergan, Merck & Co and Bristol-Myers Squibb.

Article by
Lucy Parsons

26th November 2019

From: Research



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