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. Present endometriosis treatments have limitations in efficacy or cause harmful side effects due to estrogen depletion. Finland-based Forendo Pharma, a clinical stage drug development company focusing on novel treatment’s in women’s health, announced it successfully completed its Phase 1a study of its FOR-6219, an HSD17B1 inhibitor for the treatment of endometriosis. A randomized, 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.
The Finish sponsor reports in its press release that its first-in-human study included single doses for FOR-6219 from 2mg up to 175 and multiple doses up to 150mg twice daily for 10 days were found to be safe and well tolerated.
One grade 1 (mild) adverse event (AE) was 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.
Forendo Pharma is a privately held drug development company, with core competences in modulating tissue specific hormone mechanisms. The company was founded in 2013 by leading academic endocrinology experts and Finnish drug development pioneers. Forendo is supported by strong international investors: Novo Seeds, Karolinska Development, Novartis Venture Fund, Vesalius Biocapital, M Ventures and Innovestor. The company’s pipeline includes FOR-6219, an HSD17B1 inhibitor for the treatment of endometriosis (phase I); inhibitor of another enzyme from the HSD17B family for the treatment of undisclosed gynecological condition (discovery); and Fispemifene, a novel SERM for the treatment of male urological conditions (phase 2).Source: PR Newswire