Endometriosis is a disorder in which the endometrial tissue that line the inside of the uterus grows out the uterus and is known to cause severe pelvic pain, menstrual pain, lower abdominal pain, and infertility which occurs in about 10% of women in childbearing age.
Uterine myoma is the most common benign tumor that occurs in the uterus, and is a condition that accompanies symptoms such as pain, excessive menstruation, dysfunctional uterine bleeding, and urinary incontinence which is a common disease that occurs in about 30% of women in childbearing age. Both diseases are chronic diseases, and patients are demanding safer treatments with fewer side effects for long-term use due to serious side effects such as bone loss of existing treatments.
The candidate material for the NCE403 project, TU2670, is a GnRH antagonist which can bind to pituitary receptors to suppress the secretion of gonadotropins [LH(luteinizing hormone) and FSH(follicle-stimulating hormone)].
The existing treatment with GnRH agonist, lowers patient comfort levels as it’s in an injection form and inhibits sex hormones to the level of menopause, resulting in serious side effects such as bone loss, which makes patients less comfortable. The TU2670 is an oral GnRH antagonist that only suppresses hormone levels to the level of efficacy, improving both side effects and ease of use. In addition, being a sex hormone control mechanism, it allows for indication expansion to precocious puberty, test-tube baby, infertility treatment, etc.
We have currently completed the clinical phase 1b trials in Europe (Germany) for global market launch after clinical phase 1a trial in Korea. In 2019, we signed a technology transfer contract with Daewon Pharmaceutical for domestic rights, and in July 2020, we applied for the EU Phase 2a for endometriosis and the domestic Phase 2a for uterine myoma, and are about to enter Phase 2a for clinical trials.