First Subjects Dosed in Australian Phase I Clinical Study of a Denosumab Biosimilar
- Category: Antibodies
- Published on Monday, 18 May 2020 18:18
- Hits: 1028
HSINCHU, Taiwan I May 18, 2020 I JHL Biotech, Inc. today announced that the first group of subjects has been randomized and dosed last week in the company's Australian Phase I Clinical Trial of JHL1266 in healthy subjects.
The Three-Arm Study is randomized, double-blinded, parallel-grouped, and single-dosed and will compare the pharmacokinetic similarity of JHL1266 versus Prolia® sourced from the EU and the US in healthy human subjects. It is one of the pivotal studies for registration with the ultimate objective to evaluate the similarity in Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity.
JHL1266, a proposed biosimilar to denosumab, is a monoclonal antibody targeting RANKL and works by inhibiting the development of osteoclasts and then preventing break down of bones in the human body. The targeted indications include the treatment of osteoporosis, bone metastases, giant cell tumors of bone, and other treatment-induced bone loss.
"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. "I am very proud of this achievement especially considering the COVID-19 pandemic. This is a significant milestone for JHL and a tremendous step forward in our mission to increasing public access to safe, effective, and high-quality biologics."
About JHL Biotech, Inc.
JHL is a biopharmaceutical company established in 2012 and after a transformation under new executive leadership led by James Huang, Chairman and CEO (also Managing Director of KPCB China), JHL continues to focus on three biotech sectors: 1) Accelerating the development programs for clients through the provision of Contract Development and Manufacturing Services (from cell line development to commercial manufacturing with regulatory filing support; 2) Developing a Proprietary Biosimilar Pipeline; and 3) Collaborating & Licensing of New and Innovative Biologics.
SOURCE: JHL Biotech