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.
Enteris plans to evaluate Ovarest™ in a randomized, open-label, parallel-group, active-control Phase 2a pharmacokinetics (PK) / pharmadynamics (PD) study in 38 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 lueprolide formulation approved for the treatment of endometriosis, Lupron Depot, a monthly intramuscular injection.
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.