Enteris BioPharma recently completed enrollment and initial dosing of all participants in an additional treatment arm of a Phase 2a clinical trial evaluating Ovarest, an oral leuprolide tablet, for the treatment of endometriosis.
The additional treatment arm is designed to examine improved formulation and a higher dose of Ovarest in 12 healthy volunteers. The trial expansion follows the successful completion of the study’s three initial treatment arms.
“Expansion of the Phase 2a study is a key advancement in the development of Ovarest as it provides an opportunity to explore the potential efficacy of a higher dose and improved formulation of our oral tablet product in the treatment of endometriosis,” Joel Tune, CEO and executive chairman of Enteris BioPharma, said in a press release.
“With all 12 subjects in the additional treatment arm having successfully received their initial dose, we now look forward to reporting data early in the third quarter and, following that, initiating the anticipated Phase 2b study. Endometriosis remains a severely underserved market due to challenges with the currently-approved, injectable treatments. Ovarest has the potential to meet this critical patient need with this proven and well-understood drug. It has the potential to capture a significant portion of the endometriosis market.”
The additional treatment arm is part of a Phase 2a (NCT02807363) randomized, open-label, parallel-group, active-control pharmacokinetics (PK)/pharmadynamics (PD) study of Ovarest. PK and PD refer to the study of the drug movement within the body, and its effects and mechanism of action, respectively.
The clinical trial was designed to determine the safety and PK/PD metrics of two different oral doses of Ovarest in comparison with the leuprolide formulation approved for the treatment of endometriosis, Lupron Depot, a monthly intramuscular injection.
Ovarest offers a daily oral treatment of leuprolide, an alternative to monthly leuprolide depot injections, as well as to oral hormonal contraception for the treatment of endometriosis.
The primary outcome measure in this study is adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 40 pg/mL (picogram/milliliter), from treatment day 22 to 29.
Data from previous reports of the Phase 2a study suggest that Ovarest significantly suppressed estradiol E2, showing an effect that is correlated with endometriosis.
In a Phase 1 trial in 14 healthy volunteers, no notable safety concerns were recorded and Ovarest was overall well-tolerated by study participants.
Ovarest uses Enteris BioPharma’s novel formulation technology called “Peptelligence,” a proprietary platform that enables oral delivery of molecules that are usually injected, including peptides.
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