Enteris BioPharma will discuss the potential of its oral peptide drug Ovarest (leuprolide tablet) to treat endometriosis at the upcoming 24th Annual Future Leaders in the Biotech Industry Conference.
At the April 7, to take place at New York’s Millennium Broadway Hotel & Conference Center, Enteris CEO Joel Tune will present his company’s growth strategy. Prior to joining Enteris in July 2013, Tune spent 28 years with Baxter HealthCare; his last position there was vice-president and general manager of Baxter’s $800 million BioPharma Solutions business unit.
Enteris, based in Boonton, N.J., says treatment of endometriosis may include monthly injections of leuprolide and oral hormonal contraception, which have limited efficacy in controlling disease symptoms. Oral daily Ovarest can, thus, be a valuable and attractive alternative for endometriosis patients.
A Phase 1 study with 14 healthy participants reported no safety issues after treatment with Ovarest.
Enteris will further evaluate the drug’s efficacy and safety in a randomized, open-label, parallel-group, active-control Phase 2a clinical trial (NCT02807363). The study will enroll 38 healthy participants, who will be assigned to receive two different oral doses of Ovarest. Results will be compared to those of individuals treated with a monthly intramuscular injection of leuprolide (Lupron Depot).
About six million American women have endometriosis, an estrogen-dependent inflammatory process that usually affects the ovaries, pelvic peritoneum, utero-sacral ligaments, Douglas pouch, vagina, rectum and bladder. Other regions outside the pelvis can also be affected but their location makes diagnosis more difficult.
Common endometriosis symptoms include pelvic pain and fertility problems, as well as painful, debilitating menstrual cramps, which may get worse over time; pain during or after sex; pain in the intestine or lower abdomen; painful bowel movements or painful urination during menstrual periods; heavy menstrual periods; premenstrual spotting or bleeding between periods; painful bladder syndrome; digestive or gastrointestinal symptoms similar to a bowel disorder; and fatigue, tiredness or lack of energy.
No cure exists for endometriosis, though some treatments are available to manage pain and fertility problems associated with the disease.
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