Takeda Grants Aska Licensing Rights in Japan to Relugolix for Endometriosis, Uterine Fibroids

Takeda Grants Aska Licensing Rights in Japan to Relugolix for Endometriosis, Uterine Fibroids

Takeda has granted commercialization rights to Aska Pharmaceuticals in Japan for the investigative therapy relugolix for the treatment of uterine fibroids, and development and commercialization rights for the treatment of endometriosis.

Takeda has the commercial rights for relugolix in Japan and parts of Asia. In other regions, commercialization rights are held by the biopharma Myovant Sciences, which was formed by Takeda and Roivant Sciences in June 2016.

Relugolix is an oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist.

By inhibiting GnRH receptors in the anterior pituitary gland, relugolix reduces the circulating gonadotropin luteinizing hormone and follicle-stimulating hormone, leading to the suppression of estrogen in women and testosterone in men. Suppressing these hormones improves the symptoms of uterine fibroids and endometriosis in women, according to Myovant.

Results from two Phase 3 clinical studies in Japan showed that the drug lessened menstrual blood loss and pain associated with uterine fibroids.

In one of trials (NCT02655237), researchers compared the effectiveness and safety of relugolix to leuprorelin (brand name Lupron).

The  proportion of patients who reported less menstrual blood loss was 82.2% in women treated with relugolix, demonstrating the therapy’s non-inferiority compared to leuprorelin.

In the second Phase 3 study (NCT02655224), researchers evaluated the effectiveness and safety of relugolix as a pain treatment for uterine fibroids compared to placebo.

The results showed that 57.6% of women who took relugolix showed a significant improvement in pain symptoms. In the placebo group, only 3.1% of women reported improvements.

Myovant has two ongoing Phase 3 trials, called SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331). The trials are testing relugolix for endometriosis-related pain, and are being conducted at many sites in the U.S. They are both still recruiting and are expected to enroll 600 participants each. For information on enrolling in these studies, click on the clinical trial numbers above.

Premenopausal women ages 18 to 50 with endometriosis will be included in the studies. They will receive either oral doses of placebo or 40 mg of relugolix once daily for 24 weeks, with or without a hormonal add-back therapy of low-dose estradiol and norethindrone acetate. These hormones are administered to offset the potential effects of relugolix on hormone levels and bone mineral density.

The two Phase 3 trial are expected to completed in June 2020.

The company is also conducting and recruiting patients for a Phase 3 program investigating relugolix in women with heavy menstrual bleeding associated with uterine fibroids — the LIBERTY 1 (NCT03049735), LIBERTY 2 (NCT03103087) and LIBERTY-EXTENSION (NCT03412890) studies.

Takeda is a global pharmaceutical company with significant research and development initiatives. It focuses its efforts on oncology, gastroenterology, and neuroscience, as well as vaccines.

Aska is a leading Japanese pharmaceutical company that focuses on obstetrics, gynecology, and urology.