Myovant Sciences (MYOV) completed patient recruitment for SPIRIT 2, the first of two Phase III replicate trials evaluating relugolix combination therapy in women with endometriosis-associated pain, explains biotech sector expert John McCamant, editor of The Medical Technology Stock Letter.
Endometriosis (EM) is a large and underserved market opportunity with one in ten premenopausal women having the condition, and is often associated with debilitating pain, which is particularly severe during menstruation, and infertility.
Currently, the standard of care for women with moderate to severe endometriosis is invasive procedures and pain medicines, including opioids, which have significant limitations.
Orilissa — from AbbVie (ABBV) and Neurorine Biosciences (NBIX) — was recently approved and is helping educate and create a new market by being the first gonadotropin releasing hormone (GnRH) antagonist to treat endometriosis (EM) and uterine fibroids (UF).
Myovant's Relugolix is poised to become the second GnRH antagonist for treating EM and UF. While relugolix will be second to the market, the odds of clinical success are high given positive Phase II results as well as the approval and initial commercial success of Orilissa.
In our view, the MYOV drug candidate has shown both better tolerability and more convenient dosing. Additionally, relugolix will be the only GnRH antagonist combined with add-back in a single pill and a standard dose across both EM and UF.
The two Phase III readouts in endometriosis in H1:20 are key catalysts for MYOV. The next potential catalyst for MYOV will be the Phase III data for relugolix in prostate cancer in 4Q of this year.
