Sunstone Invests in Forendo’s Development of FOR-6219 for Endometriosis

Sunstone Invests in Forendo’s Development of FOR-6219 for Endometriosis

Forendo Pharma has received €5 million (approximately $5.6 million) from Sunstone Life Science Ventures to develop its lead candidate FOR-6219 for the treatment of endometriosis.

With this investment, Sunstone joins other international investors supporting Forendo’s work on developing new treatments for women’s health. These include Novo Seeds, Karolinska Development, Innovestor, Novartis Venture Fund, M Ventures, and Vesalius Biocapital III.

“Forendo’s women’s health portfolio is starting to reveal the potential of the HSD17B enzyme family in medicine and receiving increased attention from the industry and investors alike,” Risto Lammintausta, MD, PhD, co-founder and CEO of Forendo Pharma, said in a press release. “With our increased investor support, we now are in a strong position to progress and expand our clinical program with our lead molecule.”

FOR-6219 is an orally available small molecule compound designed to inhibit the activity of the HSD17B1 enzyme and regulate estrogen production, which is known to contribute to endometriosis progression.

By blocking the activity of the HSD17B1 enzyme, the investigational compound can prevent the conversion of estrone (a weak estrogen) into estradiol (a high-activity estrogen) in endometriotic tissues.

A main feature that differentiates FOR-6219 from other hormone-targeted therapies is that it can specifically act at the site of endometriosis lesions without affecting estrogen systemic levels.

Its mode of action and safety was first confirmed in a primate model of endometriosis, and is now being evaluated in Phase 1 clinical trials.

The first-in-human study (NCT03709420) of FOR-6219 enrolled 36 healthy postmenopausal women and evaluated the safety, tolerability, food effect, overall stability, and behavior in the body (pharmacokinetics) of increasing doses of the therapy.

Participants were randomized to receive a placebo or single doses of FOR-6219, ranging between 2 mg and 175 mg, or multiple doses of up to 150 mg twice daily for 10 days.

Data announced in March 2019 demonstrated that the treatment was in general safe and well- tolerated. Food was not found to have a significant impact on FOR-6219 pharmacokinetics.

Supported by these positive results, Forendo is planning a Phase 1b study in healthy premenopausal women to further demonstrate the activity of FOR-6219 and its potential to treat endometriosis.

“We are encouraged by the positive results of this first clinical study,” Lammintausta said in another press release. “The data support the continued development of FOR-6219 as a potential, truly innovative new treatment for endometriosis.”

This new trial will be supported by Sunstone and is expected to be launched this summer.

“Sunstone sees women’s health as an area of trending popularity with immense need for investment,” said Claus Andersson, general partner at Sunstone. “Endometriosis is a perfect example, as approximately 8% of all premenopausal women are affected, suffering moderate to severe pain, infertility and impaired quality of life.”