Nyrada (ASX:NYR) has completed a pilot preclinical study testing repeated subcutaneous dosing of its lead candidate Xolatryp in combination with the chemotherapy drug doxorubicin.
The small two-week study, conducted in mice, was designed to assess the feasibility and tolerability of the intended dosing regimen and to help select doses for a larger cardiomyopathy study rather than to demonstrate definitive efficacy.
Mice received doxorubicin at 5 mg per kg intravenously once weekly for two weeks while Xolatryp was given subcutaneously four times daily for three consecutive days at total doses of 12 mg per kg per day and 36 mg per kg per day. The planned regimen was completed as designed, and Xolatryp was generally well tolerated with no unexpected safety observations. There were no significant or dose-dependent changes in body weight or liver enzymes.
At study end, plasma cardiac troponin I, a clinically relevant marker of cardiac injury, showed numerically lower mean levels in both Xolatryp treatment groups compared with the doxorubicin plus vehicle control group. The company said these preliminary biomarker findings provide initial evidence supporting further investigation of Xolatryp for cardioprotection in the setting of anthracycline chemotherapy.
Nyrada plans a larger, adequately powered cardiomyopathy study to evaluate about 12 animals per group over five weeks using clinically relevant doxorubicin exposure and comprehensive cardiac assessments, including biomarkers, cardiac function, and histopathology. The company expects results from that study in the third quarter of 2026.