Calliditas Therapeutics AB announced that the U.S. Food and Drug Administration has granted orphan drug designation to the company for the treatment of Alport syndrome with setanaxib. “Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023,” the company stated. “We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products,” added CEO Renee Aguiar-Lucander.
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