06 March 2019 | News
Enteris' lead program, Ovarest, is designed to address a key endometriosis patient need by enabling the oral delivery of leuprolide
Image Credit: ALDEGroup
Enteris BioPharma, a biotechnology company developing innovative drug products built around its proprietary delivery technologies, announced its support for Endometriosis Awareness Month, designated as the month of March. Recognizing the work that is being done by nearly a dozen U.S. organizations and associations to raise awareness of endometriosis, Enteris joins with these groups in exploring patient treatment options to help relieve symptoms and find a cure for this debilitating disease.
According to recent reports, more than six million women in the United States suffer from endometriosis. With limited approved therapeutic options to treat the discomfort and pain, the most effective approved treatment option for endometriosis entail GnRH agonists, with leuprolide being the most widely used agent in this class of drug.
Leuprolide, while effective, has significant limitations in both convenience and tolerability, which are largely attributable to its depot injection delivery method (Lupron Depot). Utilizing its proprietary Peptelligence technology, Enteris is developing an oral tablet formulation of leuprolide called Ovarest that offers the convenience of a pill, while addressing the significant limitations in convenience and tolerability attributable to the depot injection delivery method. Data from the most recent Phase 2a clinical study indicated that Ovarest enabled significant suppression of estradiol (E2), demonstrating a measurable pharmacodynamic effect that is tightly correlated with efficacy in endometriosis.
"Endometriosis remains an underserved market due to the challenges women face with currently-approved injectable treatments," said Joel Tune, CEO and Executive Chairman of Enteris BioPharma. "We believe that Ovarest has the potential to meet a critical patient need by enabling leuprolide to be delivered as an oral tablet instead of a depot injection. With the added flexibility of daily oral dosing and rapid reversibility, we believe more patients could benefit from this drug, and we are looking forward to advancing Ovarest into a Phase 2b trial."
Endometriosis is an estrogen-dependent, chronic, inflammatory disease characterized by the appearance and growth of endometrial cells or tissues in locations outside the uterus. Sources suggest endometriosis affects millions of women in the United States, with the vast majority of patients remaining undertreated due to the limitations of current options. There is no cure for endometriosis, and the associated pain is currently managed with oral contraceptives, progestins, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists of which Lupron Depot is the standard of care.