Merigolix Phase 2a Trial Success for Moderate to Severe Endometriosis Pain

TiumBio, a biopharmaceutical firm dedicated to developing treatments for rare and incurable diseases, has reported encouraging results from its Phase 2a clinical trial of Merigolix, an oral medication designed to target the gonadotropin-releasing hormone (GnRH) receptor. The drug is being tested for its efficacy in managing pain associated with endometriosis, a condition affecting approximately 200 million women globally and causing severe pelvic and menstrual pain.

The clinical trial, which took place across five European countries, involved 86 female patients with moderate to severe endometriosis-associated pain. Participants were randomly assigned to receive either Merigolix at varying doses (120 mg, 240 mg, and 320 mg) or a placebo once daily for a period of 12 weeks. The effectiveness of the treatment was gauged by measuring the mean dysmenorrhea score using the Numeric Rating Scale (NRS), which showed significant improvements in the Merigolix groups compared to the placebo.

The 120 mg dose of Merigolix demonstrated a 4.3 point reduction in dysmenorrhea scores, the 240 mg dose showed a 5.4 point reduction, and the highest dose of 320 mg resulted in a 6.2 point reduction. In contrast, the placebo group reported a 2.7 point reduction. The drug was found to be well-tolerated with no serious treatment-related adverse events, and the most common side effects were hot flushes, headaches, and nausea.

Hun-Taek Kim, CEO of TiumBio, highlighted the significance of these results, stating that despite the small group size, Merigolix showed significant efficacy and is poised to become a leading treatment for endometriosis. The company is optimistic about the drug's potential and is planning to advance its development.

Furthermore, TiumBio is exploring the application of Merigolix for uterine fibroids, another prevalent women's health condition. Ongoing clinical trials in China and the Republic of Korea are expected to yield positive results, which could expedite the drug's clinical development and market expansion.

Merigolix offers an orally administered alternative to traditional GnRH agonists, promising improved convenience and safety. Industry analysts predict that by 2030, the endometriosis market in seven major countries will be worth approximately $2.7 billion, with GnRH antagonist therapies projected to constitute around 70% of this market.

TiumBio's mission is to bring innovative solutions to patients suffering from debilitating diseases. Alongside Merigolix, the company has two other pipeline assets in clinical development: TU2218, an oral immune-oncology therapy, and TU7710, a novel recombinant FVIIa for hemophilia patients with inhibitors. With a strong commitment to scientific advancement, TiumBio continues to work towards improving the lives of those afflicted with rare and challenging health conditions.