Tium Bio has disclosed topline results showing that Marigolicx achieved statistical significance in the Phase 2a clinical trial for endometriosis in Europe. Based on these results, Tium Bio plans to target the global market, including Europe.
Marigolicx, developed by Tium Bio, is a treatment for endometriosis. This condition occurs when endometrial tissue implants and grows outside the uterus, causing pain such as dysmenorrhea and dyspareunia, as well as infertility. It frequently affects 10-30% of women of reproductive age, with an estimated 200 million patients worldwide. The market size for endometriosis treatments in the Group of Seven (G7) countries is projected to reach $2.7 billion (approximately 3.7 trillion KRW) by 2030.
Marigolicx works by acting on the receptors of gonadotropin-releasing hormone (GnRH) to suppress estradiol, a female hormone that worsens endometriosis, thereby producing therapeutic effects. Although new GnRH-based drugs have been developed to overcome the issues of existing male hormone-based drugs that induce temporary menopause, these also have problems such as causing osteoporosis and low response rates. Tium Bio explains that Marigolicx offers higher response rates while reducing bone loss compared to existing GnRH-based drugs.
In this clinical trial, the primary endpoint of reducing dysmenorrhea was confirmed compared to placebo, with no patients experiencing serious adverse reactions. According to topline data from the clinical research organization (CRO) IQVIA, Marigolicx showed statistically significant reductions in dysmenorrhea compared to placebo across all dose groups of 120, 240, and 320 mg. At 12 weeks of treatment compared to baseline, the average pain score reductions were 4.3 points for the 120 mg group, 5.4 points for the 240 mg group, and 6.2 points for the 320 mg group. In contrast, the placebo group showed an average reduction of only 2.7 points. Additionally, no patients experienced serious adverse reactions related to the treatment in terms of safety.
The clinical trial was conducted in five European countries, including Italy, Poland, and the Czech Republic, targeting patients with moderate to severe endometriosis. It was a randomized, double-blind, placebo-controlled study in which three doses of Marigolicx or placebo were administered orally once daily for 12 weeks.
Kim Hoon-taek, CEO of Tium Bio, said, "We are pleased to have secured statistically significant efficacy and safety results compared to placebo at all doses," adding, "We confirmed remarkable clinical effects in terms of dysmenorrhea reduction rate and safety data compared to existing endometriosis treatments on the market."
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