Calliditas starts Phase 2b/3 study for liver condition

 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the first patient has been randomized in the company's pivotal phase 2b/3 TRANSFORM study in patients with primary biliary cholangitis (PBC).

The TRANSFORM trial is a 52-week, randomized, placebo-controlled, double-blind, adaptive Phase 2b/3 trial. It will initially investigate the effect of setanaxib 1200 mg/day and 1600 mg/day versus placebo on alkaline phosphatase (ALP) reduction in patients with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA). Key secondary endpoints include change from baseline in liver stiffness, assessed by transient elastography (FibroScan®), and change from baseline in fatigue.

An interim analysis will be conducted once the 99th randomized patient has completed the Week 24 visit, which is expected H1 2023. The interim analysis outcome will determine which of the two doses will be selected for the Phase 3 portion of the trial.

"We are very excited to be able to launch our next pivotal trial in an orphan indication, following the recent success of our NefIgArd trial. We are committed to providing innovative solutions to address the unmet medical needs of patients with rare diseases", said CEO Renée Aguiar-Lucander.

This global study will randomize a total of ~318 patients at up to 150 investigational centres, and expects to read out top line data in H2 2024/H1 2025. As previously reported in August 2021, Calliditas received FDA Fast Track Designation for setanaxib in PBC. Further details of the TRANSFORM study can be found at www.clinicaltrials.gov, with the reference NCT05014672.

https://finance.yahoo.com/news/first-patient-randomized-pivotal-transform-094000923.html