ObsEva SA (NASDAQ:OBSV) has announced a publication in the Fertility and Sterility Journal of “Gonadotropin-releasing Hormone Antagonist (linzagolix): a New Therapy for uterine adenomyosis.” This is a case study report form its pilot study evaluating linzagolix’s use in uterine adenomyosis treatment.
Adenomyosis is an unmet medical need condition
Adenomyosis is a condition driven by estrogen, whereby endometrial tissue is usually present in the muscular uterine wall (myometrium). It results in heavy menstrual bleeding, uterine enlargement dysmenorrhea, and infertility. Normally it affects around 20% and 35% of women in reproductive age and can co-exist with uterine fibroids and/or endometriosis. The main definitive treatment for this condition is hysterectomy that is used by less than 10% of patients since it ends fertility and can have long-term adverse effects. Therefore there is an unmet medical need in this area that requires long-term and effective medical therapy.
The pilot study was an open-label, single-center study that assessed eight women that has indicative adenomyosis confirmed by MRI. The patients received 200mg of linzagolix for twelve weeks, followed by a 100mg dose for another 12 weeks without hormonal ABT. The primary efficacy measure was uterine volume reduction, as measured by magnetic resonance imaging.
Results of linzagolix treatment showing promise
The subjects the case report describes presented with heavy menstrual bleeding, pelvic pain, infertility, and anemia. There was a significant reduction in uterine volume according to MRI with adenomyotic lesions regression. In the following 12-week 100mg dose course, there was the alleviation of the symptoms, but patients remained amenorrheic. The study established that there were persistent linzagolix effects after 8 weeks following treatment completion.
Dr. Jacques Donnez, the co-author of the paper and leading gynecologist, indicated that the clinical results showed significant linzagolix effect in patients with adenomyosis. Jacques added that the results were promising for women and physicians who, for decades, have struggled to treat this condition. Similarly, the data also indicates beginning with a high linzagolix dose course without add-back therapy and then followed with a low-dose maintenance therapy could be an effective treatment approach for adenomyosis.