Calliditas Therapeutics has been granted Fast Track designation by the US Food and Drug Administration (FDA) for its NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.
“We are delighted to receive Fast Track designation and look forward to working closely with the FDA towards our aim of establishing setanaxib as the potential first NOX inhibitor for PBC patients,” said CEO Renée Aguiar-Lucander.
In a Phase II clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favourable tolerability profile, as well as a statistically significant impact on fatigue. Following positive results from a Phase I study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase II/III study in PBC, starting in the second half of 2021.