Ovarest Oral Tablet Shows Promise in Phase 2a Clinical Trial

Ovarest Oral Tablet Shows Promise in Phase 2a Clinical Trial

An oral tablet version of Ovarest (leuprolide) has shown promising results in a Phase 2a clinical trial (NCT02807363) for the treatment of endometriosis, the trial’s sponsor, Enteris BioPharma, recently announced.

Ovarest is engineered as an oral tablet form of leuprolide, a synthetic gonadotropin-releasing hormone analog. Leuprolide injections currently are used in the treatment of endometriosis, prostate cancer, and precocious puberty.

The study, conducted with healthy volunteers, showed that oral Ovarest significantly suppresses estradiol, a form of estrogen, suggesting its effectiveness in treating endometriosis.

Enteris developed Ovarest by using the company’s proprietary Peptelligence platform, an innovative oral drug technology for compounds that usually are injected. Researchers showed that Peptelligence is effective in delivering therapeutics based on peptides and other small molecules with low oral bioavailability, or the amount and rate at which a drug enters the body’s circulatory system.

“The positive results from the phase 2a clinical trial of Ovarest are a significant advancement towards Enteris’ goal of developing the first-ever oral leuprolide tablet for the treatment of endometriosis,” Joel Tune, CEO and executive chairman of Enteris, said in a press release. “We look forward to advancing the Ovarest program into a phase 2b trial.”

The company plans to launch its Phase 2b study in late 2018 and expects results to meet the requirements for a Phase 3 trial.

In addition to treating endometriosis, Enteris intends to “begin development of additional indications for oral leuprolide including uterine fibroid tumors and prostate cancer,” Tune said. “Multiple other potential indications, such as use in in vitro fertilization (IVF) protocols and central precocious puberty, can be envisioned which may contribute to further significant commercial success.”

Tune added, “The ongoing progress of Ovarest provides important additional validation of our internal pipeline and our Peptelligence platform, which has successfully enabled the oral delivery of peptides and small molecules in multiple clinical settings.”

Enteris also plans to partner with investment firm Torreya Partners. The collaboration will focus on Ovarest, Tobrate (tobramycin), a potential medication for uncomplicated urinary tract infections, and Sandostatin (octreotide), a synthetic analog of the natural hormone somatostatin. Octreotide was first used in the treatment of acromegaly, the excessive production of growth hormone in adulthood.

Enteris is also conducting several external development programs with its oral delivery technology. These include Tarsa Therapeutics‘ TBRIA (calcitonin), an oral therapy candidate for patients with postmenopausal osteoporosis, and Cara Therapeutics‘ CR845, a potential medication for chronic pain and chronic kidney-induced pruritus, or severe itching.