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Calliditas announces supportive interim data from Phase 2 trial with setanaxib

Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX), commonly referred to as "Calliditas," has released preliminary data from their Phase 2 trial aimed at studying the impact of their key NOX 1 and 4 inhibitor product candidate, setanaxib, on patients with squamous cell carcinoma of the head and neck (SCCHN). The recent findings indicate promising early clinical progression-free survival (PFS) outcomes and imply support for setanaxib's anticipated anti-fibrotic function. The preliminary evaluation was established on a data collective of 20 individuals diagnosed with recurrent or metastatic SCCHN. Out of these, 16 patients had measurable tumor size and PFS outcomes. There were twelve patients whose pre and post-treatment tumor biopsies were fitting for biomarker analysis, which evaluated transcriptomic analysis and pathology markers like SMA, PDL-1 CPS, and Foxp3 regulatory T cells. However, due to the limited sample size and variability of the patient group, the interim analysis findings should be treated with restraint. The transcriptomic evaluation disclosed that the two primary pathways influenced by the treatment were fibrosis-related signaling pathways, backing up setanaxib's presumed anti-fibrotic mode of action. On the other hand, the pathology evaluation indicated the potential of increased immune activity within tumors of patients treated with setanaxib, demonstrating positive changes in PDL-1 CPS and Foxp3. For progression-free survival (PFS), 7 out of the 16 patients suitable for evaluation showed either stable disease or partial response, six of whom were treated with setanaxib. At the time of this data's release, six of the seven patients remained on the trial drug, with the longest period on the medication for any patient accounting for 21 weeks. CEO Renée Aguiar-Lucander expressed enthusiasm for the preliminary results and the future of setanaxib in addressing diseases where treatment options are currently limited. CMO Richard Philipson echoed this sentiment, emphasizing the need for new effective treatments within this patient group and expressing anticipation for the progression of the research study. The ongoing research trial is organized as a randomized, placebo-controlled, double-blind, Phase 2 study. It aims at determining the effects of setanaxib in combination with pembrolizumab, with the aim of treating at least 50 patients with moderate or high CAF-density tumors. Current plans indicate that final data from the study will be available in 2024.


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