Forendo Pharma has received clinical trial authorization (CTA) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to commence a study for its lead program FOR-6219.
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. They often lead to systemic estrogen depletion, with known safety issues on bone mineral density and menopausal symptoms.
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Forendo Pharma has developed a potential new treatment for endometriosis based on inhibition of the HSD17B1 enzyme, a novel drug target for tissue specific regulation of hormone activity. Proof of efficacy for this novel mechanism has been demonstrated in primate model of endometriosis. The clinical compound FOR-6219 inhibits the conversion of low potency estrone into highly potent estradiol in endometriotic tissues. The most important expected differentiator of FOR-6219 compared to currently available treatments is its selective activity and the ability to act locally in the target tissues, without impacting systemic hormone levels.
The Phase Ia trial is a randomized, double-blind, placebo-controlled study in healthy postmenopausal women aged between 45 and 65 years. The primary objectives of the study will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of FOR-6219. Results are expected at end of 2018.
"Commencing the first clinical study of FOR-6219 marks an important milestone for Forendo Pharma. 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, Risto Lammintausta, CEO of Forendo Pharma, said. “We are excited by the significant clinical applications and commercial opportunities it holds for Forendo Pharma."