WALTHAM, Mass. and SHANGHAI, China, May 17 (Bernama-GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, today announced the submission of an investigational new drug (IND) application to the China National Medical Products Administration (NMPA) for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). This study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.
“The ZB001 IND submission to the NMPA marks a significant milestone for Zenas,” said Hua Mu, MD, PhD, Chief Executive Officer at Zenas. “There are currently no approved therapies for TED patients in China. Treatment options are limited and often involve high doses of steroids associated with serious side effects or surgical intervention. ZB001 has the potential to change the treatment paradigm for TED patients in China.”ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) for the treatment of TED. TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye, which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to the orbit, eye muscles and eyelids.
Zenas BioPharma licensed the exclusive rights to develop, manufacture and commercialize ZB001 (Viridian VRDN-001) and other compounds targeting IGF-1R in non-oncology indications in the greater area of China from Viridian Therapeutics, Inc. (Viridian) in October 2020. In October 2021, Viridian submitted an IND for VRDN-001 to the U.S. Food and Drug Administration and in December 2021 initiated a Phase 1/2 clinical trial to evaluate proof of concept in TED patients in North America.
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