First Healthy Volunteer Dosed in Phase 2 Ovarest Trial

First Healthy Volunteer Dosed in Phase 2 Ovarest Trial

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 SanofiFerring Pharmaceuticals, and KeyBioscience AG, a subsidiary of Nordic Bioscience, to develop orally administrated tablet formulations of medicines owned by these companies.

2 comments

  1. Stacey says:

    I really wish they would stop rehashing old drugs that haven’t helped anyone long term. A pill form of Lupron? Research money and time could be better spent elsewhere. Lupron isn’t a cure, any way it’s used. In England they have had a 98% cure rate with Immunotherapy in studies; women leaving with no endometriosis and it hasn’t grown back (all stages). Hormonal therapies have only been a bandaid and the disease still spreads during their use.

  2. nancy petersen says:

    Stop saying to TREAT ENDOMETRIOSIS, leuprolide does not treat endo. Misleading doctors and patients alike on this issue should be malpractice. Bone loss, ovarian failure, memory issues all were underreported in the past, and there is no reason to believe an oral form of the medication will do less harm. At least one study participant reported significant bone loss while on the trial and the investigator refused to do a dexascan to document, she had to do that on her own.

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