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 BioPharma recently 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, as well as other pharmaceutical products with proven efficacy in the treatment of endometriosis. 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.