Dual regimen could open door for patients with inflammatory conditions

Researchers evaluated whether a dual therapy may be safe and effective in future patients with inflammatory diseases.

In a first-in-human Phase 1 trial published in the British Journal of Clinical Pharmacology, the researchers randomly assigned nearly 100 healthy adult participants to receive either the tyrosine kinase-2/Janus kinase-1 inhibitor SDC-1801 or placebo in three parts at different daily dosages and frequencies — with the goal of examining the treatment’s safety, tolerability, pharmacokinetics, pharmacodynamics and food effects.

The researchers reported low to moderate variability, no consistent dose-exposure relationships and bioavailability that appeared solubility limited. The dual therapy was found to promote anti-inflammatory responses, particularly among interferon-gamma-induced protein-10, high-sensitivity C-reactive protein, and signal transducer and activator of transcription proteins at higher doses. Further, there were no significant severe treatment-related or treatment-emergent adverse events and no deaths linked to the treatment, demonstrating its potential safety.

The findings indicated that SDC-1801 may be well tolerated and safe at either one or two doses per day. The researchers emphasized that the positive results could present a new treatment avenue in patients with autoimmune and inflammatory diseases.

Read more: British Journal of Clinical Pharmacology

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