Forendo Pharma, a clinical stage drug development company focusing on novel treatments in women’s health, today announces that it has successfully completed Phase 1a study of FOR-6219, an HSD17B1 inhibitor for the treatment of endometriosis.
The randomised, double-blind, placebo-controlled study investigated the safety, tolerability, food effect and pharmacokinetics of single and multiple ascending oral doses of FOR-6219 in 36 healthy postmenopausal women.
In this first-in-human study, single doses of FOR-6219 from 2 mg up to 175 mg and multiple doses up to 150 mg twice daily for 10 days were found to be safe and well tolerated. Only grade 1 (mild) adverse events (AEs) were reported and none of the AEs led to study discontinuation. The pharmacokinetic results showed a dose proportionate exposure and no significant food effect.
The safety and pharmacokinetic profile support the initiation of Phase 1b clinical trial in healthy premenopausal women with the aim to demonstrate Proof of Mechanism. The selective ability of FOR-6219 to inhibit local estrogen production in the endometrium and endometriotic lesions without suppressing women’s systemic estrogen levels is expected to be the key differentiation against competing endometriosis therapies. Phase 1b study is planned to be initiated in the summer this year.
Endometriosis is a chronic condition that affects up to 10% of women in reproductive age and causes repeated pain symptoms, infertility and impaired quality of life. Currently available treatments for endometriosis have limitations in efficacy or cause harmful side effects, due to estrogen depletion.