Ovarest® (oral leuprolide tablet) is our most advanced product candidate and is being evaluated for several treatments including orphan indications.
Enteris BioPharma completed a randomized, open-label, parallel-group, active-control Phase 2a pharmacokinetics (PK) / pharmadynamics (PD) study in 32 healthy volunteers. Data indicate that Ovarest® achieved estradiol suppression in line with Lupron Depot®, the current standard-of-care injectable formulation. All subjects met the estradiol suppression target (estradiol ≤ 40 pg/mL) during the dosing period. NCT02807363.
In a Phase 1 trial in 14 healthy volunteers, no notable safety issues were observed for clinical laboratory tests results and treatment-induced changed in vital signs. Ovarest® was well-tolerated by the study participants.