On January 20, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX – CALTX; NASDAQ – CALT) reported it will provide information on the near-term clinical development plans for setanaxib in primary biliary cholangitis (PBC) and oncology (Press release, Calliditas Therapeutics, JAN 20, 2021, View Source [SID1234576683]). It will also present additional data from the Part A of the NefIgArd Phase 3 study, which recently reported positive data.
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In Q4 of 2020 Calliditas acquired a controlling stake in Genkyotex, which has been developing a first in class platform for NOX inhibition and where the lead compound, setanaxib has been tested in various fibrosis related indications. Following the positive results from the Phase 1 study in January of 2021, which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC, starting in 2H 2021, with final design and protocol details subject to feedback from the US Food and Drug Administration (FDA). In addition, Calliditas plans to initiate a Phase 2 proof-of-concept study in head and neck cancer this year which will study administration of setanaxib in conjunction with immunotherapy targeting CAFs (cancer associated fibroblasts).
Calliditas will also provide select data from the recently concluded Part A of the Phase 3 study NefIgArd with the lead candidate drug Nefecon, for the treatment of IgA Nephropathy. The data to be presented include overall baseline characteristics, rate of discontinuation of study treatment (9.5%) and rate of discontinuation from the study (3.5%). It is also confirmed that no adverse clinical effects were seen with regards to weight gain, blood pressure or HbA1c, reflecting a safety profile in keeping with the Phase 2b trial.
In addition, presentations on the regulatory submission process, market access and commercial preparations in the US will be included.
The R&D Day will take place between 1pm and 5pm CET today and will be webcast live and accessible at: View Source