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KUALA LUMPUR, Aug 1 (Bernama) -- Global biopharmaceutical company Zenas BioPharma announced it has received approval of its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA) of China.
This is for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED).
“We are proud that the IND application for ZB001 was approved by the NMPA about two months following its submission, highlighting our team’s unique ability to efficiently execute on our development programmes,” said Chief Executive Officer at Zenas, Hua Mu, MD, PhD.
According to a statement, the main objective of the Phase 1/2 is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.
ZB001 is a differentiated humanised monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) intended for the treatment of TED.
TED is a debilitating vision-threatening autoimmune disease that causes inflammation and fibrosis within the orbit of the eye.
With 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.
More details at www.zenasbio.com.
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