DAMIAN announces publication in the British Journal of Clinical Pharmacology of phase 1 data of dexfadrostat phosphate in healthy volunteers
Today DAMIAN announces the publication of study DP13C101, a phase 1 study evaluating the efficacy and safety of dexfadrostat phosphate in healthy volunteers in the British Journal of Clinical Pharmacology.
Dexfadrostat phosphate is a novel aldosterone synthase inhibitor (ASI), which acts to directly control the production of aldosterone at its origin. “By inhibiting the 3 enzymatic conversions mediated by aldosterone synthase, dexfadrostat phosphate was shown to demonstrate a dose-dependent reduction of the aldosterone-to-renin ratio (ARR, a marker of sodium retention) without affecting the adrenal stress response or the hypothalamic-pituitary-gonadal axis.”
DAMIAN announced in October 2022 the successful completion of a phase 2 study evaluating dexfadrostat phosphate in patients with primary aldosteronism. The study met both its primary endpoints (ARR, ambulatory systolic blood pressure reduction) with high statistical significance following 8 weeks of once-daily treatment. The study also demonstrated a good safety and tolerability profile.
Mulatero et al., Brit J Clinical Pharmacol. 2023 Mar 13; doi: 10.1111/bcp.15713. Online ahead of print