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 its lead program FOR-6219, a novel, tissue specific treatment of endometriosis. FOR-6219 was found to be safe and well tolerated, with good pharmacokinetics at the doses tested.
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.
The randomized, double-blind, placebo-controlled Phase 1a study investigated safety, tolerability, food effect and pharmacokinetics of single and multiple ascending doses of FOR-6219 in 36 healthy postmenopausal women.
In this first-in-human study, single doses of FOR-6219 from 2mg up to 175mg and multiple doses up to 150mg twice daily for 10 days were found to be safe and well tolerated. The pharmacokinetic results showed a dose proportionate exposure and no significant food effect.
The safety and pharmacokinetic profile of FOR-6219 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 differentiator against current endometriosis therapies on the market and in clinical development. The aim is to initiate Phase 1b study in the summer 2019.
Risto Lammintausta, CEO of Forendo Pharma, said: ” We are encouraged by the positive results of this first clinical study. It is an important milestone to Forendo Pharma. The data supports the continued development of FOR-6219 as a potential, truly innovative new treatment for endometriosis based on inhibition of the HSD17B1 enzyme, a novel drug target for tissue specific regulation of hormone activity.”