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Calliditas receives Fast Track designation

Renee Aguiar-Lucander

The US Food and Drug Administration has granted Fast Track Designation for the company’s lead 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,” says Renée Aguiar-Lucander, CEO, Calliditas.

Read more: Q&A: Renée Aguiar-Lucander, CEO, Calliditas Therapeutics

A Phase 2/3 study

In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue, states the company in a press release.

Following positive results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a Phase 2/3 study in PBC, starting in 2H 2021.

Photo of Renée Aguiar-Lucander