Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX), a Sweden-based specialty pharmaceutical company, announced on Wednesday that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for setanaxib intended for the treatment of Alport syndrome, a genetic condition characterised by kidney disease, loss of hearing and eye abnormalities.

The company is planning to start a randomised, placebo-controlled phase two clinical study in Alport syndrome with around 20 subjects in the fourth quarter of 2023, based on supportive pre-clinical work. The company's subsidiary Calliditas Therapeutics Suisse SA is to sponsor the planned phase 2 clinical study of setanaxib in Alport syndrome.

Presently, the company is assessing the product through Calliditas Therapeutics Suisse SA in a phase two proof-of-concept study in squamous cell carcinoma of the head and neck (SCCHN) and in a Phase 2b study in primary biliary cholangitis (PBC). The product is also being assessed in an investigator-led study in idiopathic pulmonary fibrosis (IPF).