Forendo joins race to develop endometriosis drugs

Finland’s Forendo Pharma is beginning early-stage trials of a potential new treatment for endometriosis, joining a gang of biotechs vying to find new therapies for the debilitating condition.

Affecting up to 10% of women of reproductive age, endometriosis is a painful condition caused by tissue normally found lining the uterus growing outside the uterus.

This tissue thickens, breaks down and bleeds during menstruation but becomes trapped, potentially leading to cysts and scarring.

Treatments are limited – doctors can prescribe painkillers and use hormone therapy to slow growth of endometrial tissue and prevent it spreading – but symptoms can return after treatment stops.

In extreme cases, women can opt for hysterectomies to regulate the hormones that cause the disease to worsen.

Forendo has developed a potential new treatment based on inhibition of the HSD17B1 enzyme, a novel drug target for tissue specific regulation of hormone activity.

The compound known as FOR-6219 has already worked in primates, where it inhibited the conversion of low potency estrone into highly potent estradiol in endometriotic tissues.

Forendo hopes that FOR-6219 will be a step forward over existing therapies because of its selective activity – it acts locally on the target tissues without impacting hormone levels elsewhere in the body.

The phase 1a trial that has been approved by the UK’s regulator is a randomised, double-blind, placebo controlled study in healthy postmenopausal women aged 45-65 years.

Primary goals are to investigate safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of FOR-6219. Results are expected later this year.

There are several other drugs in later stage development for endometriosis – Takeda has partnered with Roivant Sciences to form a startup, Myovant Sciences, to develop relugolix, a late stage treatment for endometriosis, uterine fibroids, and hormone-sensitive prostate cancer.

Enteris BioPharma is developing Ovarest, an oral formulation of leuprolide, which is in mid-stage development for endometriosis.

ObsEva’s linzagolix last month met primary and secondary goals in a phase 2b endometriosis trial. The main goal was to reduce pain, while the secondary target was based around responder rates.

Forendo is a portfolio company of Karolinska Development, which invests in breakthrough developments in the Nordic region.

It also has backing from investors including Novo Nordisk's investment vehicle, Novo Seeds.

Risto Lammintausta, CEO of Forendo Pharma, said: "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". We are excited by the significant clinical applications and commercial opportunities it holds for Forendo Pharma.”