Forendo Pharma has secured clinical trial authorisation (CTA) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase I trial of FOR-6219 to treat endometriosis.
The randomised, double-blind, placebo-controlled trial plans to enrol healthy postmenopausal women aged between 45 and 65 years.
The trial’s primary goal includes the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of FOR-6219.
Forendo is expected to release results from the trial towards the end of this year.
Forendo Pharma CEO Risto Lammintausta said: “FOR-6219 has the potential to address significant unmet needs in women’s health, and potentially offers multiple benefits over the current endometriosis therapies including long-term use, as well as the opportunity for earlier intervention to this chronic disease.”
FOR-6219 is designed to inhibit the conversion of low potency estrone into highly potent estradiol in endometriotic tissues.
Compared to the existing treatments of endometriosis, FOR-6219 can perform selective activity and has the ability to act locally in the target tissue, without impacting systemic hormone levels.
Endometriosis is a chronic condition affecting up to 10% of women in reproductive age. The disease also causes repeated pain symptoms, infertility and impaired quality of life.
The existing treatments for endometriosis have limitations in terms of efficacy or cause harmful side-effects.
They often result in systemic estrogen depletion, with known safety issues on bone mineral density and menopausal symptoms.