The first healthy volunteer has been dosed in a Phase 2a clinical trial evaluating the safety and biochemical response of Ovarest, an oral formulation of leuprolide developed by Enteris BioPharma for the treatment of endometriosis.
“Initiation of the Ovarest Phase 2a clinical trial is a significant milestone for Enteris and underscores our commitment to building an internal product pipeline of innovative oral therapeutics that address underserved medical needs in women’s health,” Joel Tune, chief executive officer and executive chairman of Enteris BioPharma, said in a press release.
Ovarest was developed from the Peptelligence platform, Enteris’ proprietary oral drug delivery technology. This technology improves the solubility and absorption of small therapeutic compounds that are commonly injected. Enteris converts these injectable medicines into oral versions without losing the compounds’ therapeutic activity.
Ovarest was developed as an oral tablet version of the FDA-approved and commercially available endometriosis treatment Lupron, a leuprolide formulation delivered by intramuscular injection and marketed by AbbVie.
Results from a Phase 1 clinical trial in 14 healthy volunteers demonstrated that Ovarest was well-tolerated, with no significant adverse effects reported.
The ongoing Phase 2a trial (NCT02807363) was designed to evaluate the safety of two dosage regimens of the oral Ovarest treatment compared with Lupron. In addition, the chemical stability of the oral therapy and its distribution in the body will be assessed.
Conducted in Canada, the study will enroll 32 healthy volunteers. Participants will be randomly assigned to receive 4 mg tablets of Ovarest administrated once or twice daily, or to receive an intramuscular injection of Lupron in a clinically meaningful dosage (3.75 mg). All participants will receive the different treatment regimens for up to 28 days.
“Endometriosis affects nearly six million women in the United States, and there have been few advancements in the space to provide these women with more patient-friendly treatment options,” Tune said. “Ovarest has the potential to become a high-value and broadly adopted therapeutic for the treatment of endometriosis.”
Earlier this year, Enteris established agreements with Sanofi, Ferring Pharmaceuticals, and KeyBioscience AG, a subsidiary of Nordic Bioscience, to develop orally administrated tablet formulations of medicines owned by these companies.
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