Forendo Pharma, a clinical stage drug development company focusing on novel treatments in women’s health, today announces initiation of dosing in a Phase 1b clinical study in its lead endometriosis program with the aim to demonstrate Proof of Mechanism. The novel oral compound, FOR-6219, is a HSD17B1 inhibitor aiming to reduce estrogen production locally in the endometriosis lesions. The first women participating in the study have been dosed.
Earlier this year, the first-in-human Phase 1a study of FOR-6219 was successfully completed. Single doses from 2mg up to 175mg and multiple doses up to 150mg twice daily over 10 days were found to be safe and well tolerated in 36 healthy postmenopausal women. The pharmacokinetics of FOR-6219 was dose-proportional and steady state was reached within 3 days. The observed elimination half-life was around 16-18 hours, offering potential for once daily dosing. The pharmacokinetic profile of FOR-6219 was similar in a fasted and fed state indicating that FOR-6219 can be administered with or without food.
In the on-going Phase 1b study FOR-6219 is given to premenopausal women to explore the effect of FOR-6219 on the endometrium by measuring changes in endometrial thickness and endometrial estrogen levels. In addition to these local effects, systemic hormone levels will also be measured. Other endpoints are based on safety and tolerability.
Risto Lammintausta, CEO of Forendo Pharma, said: “The commencement of the Phase1b study marks an important milestone for the company as we aim to demonstrate Proof of Mechanism for this novel concept in premenopausal women for the first time. The selective ability of FOR-6219 to inhibit local estrogen production in the endometrium and endometriotic lesions, without suppressing systemic estrogen levels, is unique and expected to be the key differentiator against competing endometriosis therapies. If we can demonstrate this new mechanism in healthy premenopausal women, we will have a solid basis to study FOR-6219 in endometriosis patients who need better long-term treatment alternatives for this chronic and high burden disease.”