TURKU, Finland, March 7, 2019 /PRNewswire/ -- 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 FOR-6219, an HSD17B1 inhibitor for the treatment of endometriosis.
The randomised, double-blind, placebo-controlled study investigated the safety, tolerability, food effect and pharmacokinetics of single and multiple ascending oral doses of FOR-6219 in 36 healthy postmenopausal women.
In this first-in-human study, single doses of FOR-6219 from 2 mg up to 175 mg and multiple doses up to 150 mg twice daily for 10 days were found to be safe and well tolerated. Only grade 1 (mild) adverse events (AEs) were reported and none of the AEs led to study discontinuation. The pharmacokinetic results showed a dose proportionate exposure and no significant food effect.
The safety and pharmacokinetic profile 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 differentiation against competing endometriosis therapies. Phase 1b study is planned to be initiated in the summer this year.
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.
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. This data gives a good basis to progress the development of FOR-6219 towards a truly differentiated, next generation treatment for endometriosis patients."
About Forendo Pharma
Forendo Pharma is a privately held drug development company, with core competences in modulating tissue specific hormone mechanisms. The company was founded in 2013 by leading academic endocrinology experts and Finnish drug development pioneers. Forendo is supported by strong international investors: Novo Seeds, Karolinska Development, Novartis Venture Fund, Vesalius Biocapital, M Ventures and Innovestor. The company's pipeline includes FOR-6219, an HSD17B1 inhibitor for the treatment of endometriosis (phase I); inhibitor of another enzyme from the HSD17B family for the treatment of undisclosed gynecological condition (discovery); and Fispemifene, a novel SERM for the treatment of male urological conditions (phase 2). Further information is available at www.forendo.com.
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The randomised, double-blind, placebo-controlled study investigated the safety, tolerability, food effect and pharmacokinetics of single and multiple ascending oral doses of FOR-6219 in 36 healthy postmenopausal women.
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In this first-in-human study, single doses of FOR-6219 from 2 mg up to 175 mg and multiple doses up to 150 mg twice daily for 10 days were found to be safe and well tolerated. Only grade 1 (mild) adverse events (AEs) were reported and none of the AEs led to study discontinuation. The pharmacokinetic results showed a dose proportionate exposure and no significant food effect.
The safety and pharmacokinetic profile 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 differentiation against competing endometriosis therapies. Phase 1b study is planned to be initiated in the summer this year.
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.
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. This data gives a good basis to progress the development of FOR-6219 towards a truly differentiated, next generation treatment for endometriosis patients."
About Forendo Pharma
Forendo Pharma is a privately held drug development company, with core competences in modulating tissue specific hormone mechanisms. The company was founded in 2013 by leading academic endocrinology experts and Finnish drug development pioneers. Forendo is supported by strong international investors: Novo Seeds, Karolinska Development, Novartis Venture Fund, Vesalius Biocapital, M Ventures and Innovestor. The company's pipeline includes FOR-6219, an HSD17B1 inhibitor for the treatment of endometriosis (phase I); inhibitor of another enzyme from the HSD17B family for the treatment of undisclosed gynecological condition (discovery); and Fispemifene, a novel SERM for the treatment of male urological conditions (phase 2). Further information is available at www.forendo.com.
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SOURCE Forendo Pharma
