Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves’ Ophthalmopathy
HBM9161 Receives Its Fourth IND Approval for Clinical Trials in China
CAMBRIDGE, Mass. & ROTTERDAM, The Netherlands & SUZHOU, China: Harbour BioMed (HBM) has announced that National Medical Products Administration (NMPA, China) approved its IND application for HBM9161, a full-human antibody targeting neonatal Fc receptor (FcRn), to conduct a Phase 2/3 clinical trial in patients with Graves’ ophthalmopathy (GO). The IND approval is the fourth for HBM9161 in China and the second to allow the Company to proceed directly to Phase 3 under an accelerated development pathway.
“GO is an extremely debilitating disease and with this IND we further our commitment to bringing innovative medicines to patients,” said Dr. Jingsong Wang, M.D., Ph.D., Founder, Chairman and CEO of Harbour BioMed. “We look forward to accelerating HBM9161’s clinical development in China. The approval to conduct clinical trials with HBM 9161 in GO, along with the emerging clinical programs in China for other autoimmune diseases, underscores the potential our strategy to develop this promising compound as a ‘portfolio in a product’.”
HBM9161 has also received IND clearances from NMPA to treat myasthenia gravis, neuromyelitis optica spectrum disorder (NMOSD) and immune thrombocytopenia. Phase 2 studies in all of these indications are getting under way.
Graves’ ophthalmopathy, also known as Thyroid Eye Disease, is an autoimmune inflammatory disorder which may result in permanent blindness. With limited treatment options currently available against this serious and disfiguring disease, there is still a significant unmet medical need to bring therapeutic solutions for patients. By accelerating the depletion of autoantibodies that cause GO, HBM9161 may offer a targeted treatment option for patients.
HBM licensed HBM9161 from HanAll Biopharma and has rights to develop, manufacture and commercialize the antibody in Greater China (including Hong Kong, Macau and Taiwan). HanAll has licensed rights to the antibody to Immunovant for the Americas, European Union, Middle East and North Africa. In March, Immunovant announced positive initial results of a Phase 2a proof-of-concept study of the drug (IMVT-1401) in GO.