Positive top-line results from LIONHEART Study with Agamree

Swiss specialty pharmaceutical company Santhera Pharmaceuticals’ (SIX: SANN) rose as much as 5% to .46 francs yesterday after it announced the outcome of the LIONHEART study, confirming vamorolone’s distinctive action also a a mineralocorticoid receptor antagonist, which sets it apart from other corticosteroids.

The LIONHEART study, an open-label randomized, placebo- and eplerenone-controlled study involving 30 healthy adult male subjects, met its primary endpoint. It demonstrated a statistically significant increase in the urinary sodium/potassium ratio in the vamorolone arm compared to placebo (p<0.0001) following a fludrocortisone challenge.

Santhera noted that this increased ratio in urine provides clinical evidence for vamorolone’s unique mode of action also as a mineralocorticoid receptor antagonist (MRA) in humans. Combined with its known properties as a dissociative glucocorticoid receptor agonist, these findings further differentiate vamorolone’s pharmacological profile, distinguishing it from other corticosteroids.