Calliditas reveals pivotal setanaxib data

Results are from company’s phase 2 head and neck cancer trial with lead NOX inhibitor candidate

Calliditas Therapeutics has announced interim data from its phase 2 trial treating patients with squamous cell carcinoma of the head and neck (SCCHN) with its lead NOX 1 and 4 inhibitor, setanaxib.

The wider trial is a randomised, placebo-controlled proof-of-concept study researching the effect of setanaxib 800mg twice daily in conjunction with pembrolizumab 200mg IV – administered every three weeks.

The study has duly delivered encouraging early clinical progression-free survival (PFS) results and supports the presumed anti-fibrotic action offered by setanaxib. This particular element of the research involved 20 individuals with recurrent or metastatic SCCHN. Among these, 16 patients had evaluable tumour size and PFS related results.

In addition, 12 patients had tumour biopsies before and after treatment, which were evaluable for biomarker analysis. Due to the small sample size and heterogeneity of the patient population, any inferences from the interim analysis should be treated with caution.

Transcriptomic analysis demonstrated that the two top pathways impacted by the therapy were fibrosis-related signalling pathways. This provided evidence for the mode of action relating to modulation of activated fibroblasts, as well as the continuing clinical programmes.

Meanwhile, pathology studies showed preliminary evidence of an increase in immunological activity within tumours of patients treated with setanaxib.

In regards to PFS, seven out of the 16 evaluable patients were progression-free with either stable disease or partial response. Of these, six were in the setanaxib cohort and one was in the placebo group. Six of the seven people remained on the study drug at the time of the data emerging, with the longest period on drug being reported as 21 weeks (relating to a patient in the setanaxib arm).

Renée Aguiar-Lucander, chief executive officer at Calliditas, reflected: “Based on the encouraging clinical and transcriptomic results, data clearly supports the continuation of the trial, which will read out on tumour size and progression free survival in the full trial population next year.”

She added: “Also, it is interesting that the transcriptomic results clearly pointed to beneficial impact on two fibrosis related signalling pathways, supporting the presumed mode of action as well as our pipeline programs. We are excited about the potential of setanaxib in disease areas where today treatment options are limited.”