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Calliditas Announces Positive Topline Results from Phase 2 Trial of Setanaxib, its Lead NOX Inhibitor Candidate, in Head and Neck Cancer

Monday, May 06, 2024

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) has unveiled significant findings from its Phase 2 trial investigating setanaxib, its primary NOX enzyme inhibitor, in combination with pembrolizumab for patients with squamous cell carcinoma of the head and neck (SCCHN). The analysis indicates notable improvements in progression-free survival (PFS) and overall survival (OS), along with noteworthy changes in tumor biology that align with setanaxib's mechanism of action.

This Phase 2 study was randomized, placebo-controlled, and double-blind, involving the administration of setanaxib 800mg twice daily alongside pembrolizumab 200mg IV every 3 weeks, a standard treatment regimen for SCCHN. The trial included 55 patients with recurrent or metastatic SCCHN and moderate or high CAF-density tumors (Cancer Associated Fibroblasts), all of whom had the opportunity to complete at least 15 weeks of treatment.

Results showed statistically significant improvements in key secondary endpoints for patients receiving pembrolizumab and setanaxib, including progression-free survival (median 5 months versus 2.9 months; Hazard ratio= 0.58) and overall survival (OS at 6 months 92% vs 68%; OS at 9 months 88% vs 58%; Hazard ratio=0.45), compared to those on pembrolizumab and placebo. Additionally, patients treated with setanaxib exhibited an enhanced disease-control rate, with 70% showing stable disease compared to 52% in the placebo group. Although no significant difference was observed in the primary endpoint of tumor size reduction, transcriptomic analysis revealed a substantial increase in CD8+ T-cells in tumor tissue from patients treated with setanaxib, indicating heightened tumor immunological activity congruent with setanaxib's mechanism of action. Setanaxib, when administered with pembrolizumab, demonstrated good tolerability with no identified new safety concerns.

Biological Cancer Therapies at The Institute of Cancer Research (ICR) London, and Investigator on the trial, expressed optimism, stating, "It is very encouraging to see statistical significance on important clinical outcomes in this relatively small study, which provides an excellent basis for advancing setanaxib in this hard-to-treat population."

Calliditas, also remarked on the exciting results, noting, "This is a very exciting result which provides clinical evidence of the mode of action of setanaxib in line with our thesis of its anti-fibrotic effects, and with results beyond our expectations for a study of this size."

The company is actively conducting additional clinical trials with setanaxib, with upcoming milestones including the Phase 2 trial in PBC (primary biliary cholangitis) and the investigator-led Phase 2 trial in IPF (idiopathic pulmonary fibrosis). Moreover, an ongoing Phase 2 proof of concept trial in Alport syndrome is anticipated to deliver top line data in 1H, 2025.

To share additional insights into the Phase 2 trial and other supportive data regarding setanaxib's mechanism of action, Calliditas plans to organize an R&D day in Stockholm later this month, with further details to be provided through a press release.

Head and neck cancer represents a significant global health burden, with approximately 900,000 cases and over 400,000 deaths annually worldwide. In the United States, it accounts for around 71,100 cases and 16,100 deaths annually, while in Europe, there were approximately 250,000 cases and 63,500 deaths in 2012. Males are disproportionately affected, with a ratio ranging from 2:1 to 4:1. Recurrence, especially in advanced stages, is common, with limited treatment options available.



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