Enteris BioPharma Announces Positive Results from Expanded Trial of Ovarest

Enteris BioPharma announced positive results today from the final treatment arm of the Phase 2a clinical trial of Ovarest, an oral formulation of leuprolide, for the treatment of endometriosis. Ovarest leverages Enteris' proprietary Peptelligence technology, which the Company uses to develop innovative oral drug formulations for clients, in addition to advancing its own internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities. Data indicate that the optimized formulation and dose achieved estradiol suppression in line with Lupron Depot, the current standard-of-care injectable formulation, as well as other pharmaceutical products with proven efficacy in the treatment of endometriosis. All subjects met the estradiol suppression target (estradiol ≤ 40 pg/mL) during the dosing period. Based on these positive results, Enteris plans to advance Ovarest into the next stage of clinical development.

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"The objective of the last Phase 2a treatment arm was to demonstrate that an optimized tablet formulation at a 10 mg twice daily dose would further improve estradiol suppression. We are very pleased to report that the data hit the mark, showing that Ovarest tablets are now expected to demonstrate similar efficacy to Lupron Depot and other products developed and being developed to treat endometriosis," said Joel Tune, Chief Executive Officer and Executive Chairman of Enteris BioPharma. "We now intend to advance Ovarest into a Phase 2b trial planned for later this year, which we believe is likely to establish Ovarest as a Phase 3-ready asset. It is Enteris' strategy to partner Ovarest and all its internal pipeline products either at the proof of concept stage or before they enter Phase 3."

Interim Phase 2a data from the prior arms of the study announced earlier this year indicated that Ovarest is able to suppress estradiol in a dose-proportional pattern. Results from the last Phase 2a cohort, comprised of 12 healthy volunteers, demonstrated that the optimized formulation of a 10 mg Ovarest dose administered twice daily further improved estradiol suppression. Importantly, pharmacokinetic (PK) data for this Ovarest dosing regimen indicate reliable drug delivery with leuprolide levels in the systemic circulation generally exceeding the Lupron Depot metrics. Reliable drug delivery was demonstrated by maintaining blood level concentrations well above established threshold levels for efficacy throughout the 28-day treatment period.