Taiwan-based JHL Biotech said it has initiated a phase 1 clinical trial of its denosumab biosimilar candidate for bone loss.
Hsinchu, Taiwan—based JHL Biotech said it has initiated a phase 1 clinical trial of its denosumab biosimilar candidate JHL 1266, having randomized and treated the first group of patients.
JHL 1266 is a monoclonal antibody targeting RANKL, a gene that regulates cell death. Denosumab inhibits the development of osteoclasts, which break down bone tissue and release the minerals into the blood stream. The drug thereby prevents breakdown of bones in the human body.
Denosumab is used for the treatment of osteoporosis and hypercalcemia, or above-normal calcium levels. In the United States it is indicated for osteoporosis and improving bone mass in individuals at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer.
The company said the 3-arm study is being conducted in Australia and will compare the pharmacokinetic similarity of JHL 1266 with that of the reference product, Prolia, in healthy patients. The company described the study as pivotal for regulatory approval.
“Denosumab is an important biologic for the treatment of post-menopausal osteoporosis and other common bone related diseases. Because it’s unfortunately very expensive for patients and healthcare payers, JHL1266 would provide an affordable treatment for these patients,” said James Huang, CEO of JHL Biotech, in a statement.