Ovarest® (oral leuprolide tablet) is our most advanced product candidate and is being evaluated for its potential to treat endometriosis, a painful and chronic disease that affects approximately six million women in the United States.
For women suffering with this disease, a daily oral treatment of leuprolide will offer an attractive alternative to monthly leuprolide depot injections, as well as to oral hormonal contraception, which have limited efficacy in managing endometriosis.
Ovarest® is currently being evaluated in randomized, open-label, parallel-group, active-control Phase 2a pharmacokinetics (PK) / pharmadynamics (PD) study in 32 healthy volunteers. The study will determine the safety and measure the PK/PD metrics of two different oral doses of Ovarest® in comparison to the leuprolide formulation approved for the treatment of endometriosis, Lupron Depot, a monthly intramuscular injection. 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.