Novartis has announced positive data for its NASH candidate tropifexor, building the case for the drug as it races for the coveted first-to-market label for the disease.
The interim results come from a late phase 2b study of tropifexor in patients with biopsy-confirmed advanced fibrotic non-alcoholic steatohepatitis (NASH).
The FLIGHT-FXR study assessed the safety, tolerability and efficacy of the drug in NASH patients. This condition is a type of non-alcoholic fatty liver disease (NAFLD), which causes an accumulation of fat in the liver which leads to chronic inflammation and fibrosis.
The interim analysis from the study demonstrated that higher doses of tropifexor (140 Mu g and 200 Mu g) resulted in improvements in a number of key biomarkers of NASH.
Among these was hepatic fat fraction, alanine aminotransferase (an enzyme which signals liver damage) and body weight, as well as a favourable safety profile after 12 weeks of sustained treatment.
NASH is commonly associated with obesity, diabetes and high-cholesterol – currently, there are no approved treatments for the condition, and the race to market has seen multiple pharma companies fail in late-stage studies.
This includes Gilead, whose chances of winning the first-to-market race dwindled after one of its key candidates – selonsertib – failed in a crucial phase 3 study earlier this year.
However, the company still has hopes for the drug, with results from a phase 2 trial testing selonsertib in combination with cilofexor and firsocostat due before the end of the year.
“NASH is a complex disease with currently no approved pharmacological treatments,” said Eric Hughes, global development unit head, Immunology, Hepatology and Dermatology.
“We are encouraged by the results tropifexor has shown in monotherapy while we continue to investigate its potential as a backbone therapy in combination treatments for NASH.”
The full, detailed data is due to be presented at The Liver Meeting 2019 taking place in Boston, US this week.
A number of other major pharma companies such as Pfizer, Allergan, Merck & Co and Bristol-Myers Squibb are pursuing treatments in NASH, making the race to market a close one.
The winning player will reap the rewards of an untapped market – NASH affects up to 50 million people in the US alone, and market analysts Research and Markets estimate that the market potential will reach $20.68bn by 2025, when the first treatments start to become approved.