Clinical trials are essential for evaluating the safety, efficacy, and tolerability of various therapies, as well as their impact on the patient population. According to a recent news release from the clinical-stage biopharmaceutical company Sagimet Biosciences Inc. (“Sagimet”), the company’s licensing partner, Ascletis Bioscience Co. Ltd. (“Ascletis”), is currently conducting a Phase 3 study. In this study, researchers are assessing the combined treatment of denifanstat and bevacizumab for individuals living with recurrent glioblastoma. As of now, 120 participants have enrolled.
Denifanstat, developed by Sagimet and licensed to Ascletis for studies in China, Macau, Taiwan, and Hong Kong, is an oral, selective, first-in-class fatty acid synthase inhibitor. It was initially designed for nonalcoholic steatohepatitis (NASH) with the primary goal of reducing excess liver fat and, consequently, mitigating inflammation and scarring. Denifanstat is currently under investigation in the Phase 2b FASCINATE-2 trial for this indication, with additional details on pharmacokinetics expected to be available early next year.
On the other hand, bevacizumab is a targeted cancer treatment drug. As explained by Cancer Research UK:
Bevacizumab targets a protein in cancer cells known as vascular endothelial growth factor (VEGF). This protein helps cancers grow blood vessels, enabling them to obtain food and oxygen from the bloodstream. Bevacizumab works by blocking this protein, preventing the growth of blood vessels in the cancer, ultimately starving it.
One of the challenges in treating glioblastoma is its malignant nature and difficulty to treat, as these tumors can generate their own blood supply. By inhibiting the tumor’s ability to grow blood vessels, this treatment, when combined with denifanstat, has the potential to improve survival and quality of life. However, it’s important to note that more data from this study, including an analysis of progression-free survival, will become available in the future.
Glioblastoma Overview
Also referred to as Stage IV astrocytoma, glioblastoma is a rare and highly aggressive form of brain cancer that originates from astrocyte cells. Typically, glioblastoma occurs in the cerebrum but can spread to other areas of the brain. These tumors often appear without any prior signs of a lower-grade precursor. Glioblastoma can affect individuals of all ages, though it’s more common in people over 60, and it affects both men and women, albeit more frequently in men. Additional risk factors include previous radiation therapy and certain genetic conditions. Symptoms of glioblastoma often manifest rapidly due to the tumor or brain swelling. Common symptoms include nausea, vomiting, double or blurred vision, persistent headaches, difficulty thinking or speaking, seizures, balance and coordination issues, muscle weakness or paralysis, fatigue, and changes in mood, behavior, or personality.
