Zenas BioPharma has received approval of its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA) of China to start a phase 1/2 clinical study of ZB001 to treat thyroid eye disease (TED).
The main objective of the study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.
TED is a debilitating, vision-threatening, autoimmune disease that causes inflammation and fibrosis within the eye muscles, eyelids, tear glands and fatty tissue behind the eye.
This can cause the eyes and eyelids to become red, swollen and uncomfortable and the eyes can be ‘pushed forward’, giving the impression of staring or bulging eyes.
TED occurs when the body’s immune system attacks the tissue surrounding the eye. In most patients, the same autoimmune condition that causes TED also affects the thyroid gland, resulting in Graves’ disease.
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.
ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) intended for the treatment of 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 programs,” said Hua Mu, Zenas’ CEO.
“We are excited to work with leading clinical experts in China to accelerate the development of ZB001 to address the significant unmet clinical need in thyroid eye disease.”
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 China area from Viridian Therapeutics, Inc. in October 2020.
After submitting an IND for VRDN-001 to the U.S. Food and Drug Administration in October 2021, Viridian initiated a phase 1/2 clinical trial in December 2021. This was to evaluate proof of concept in TED patients in North America. The company said encouraging interim healthy volunteer data suggested robust activity with excellent safety and tolerability of the candidate product.
About Zenas BioPharma
Zenas BioPharma is a global biopharmaceutical company based in the U.S. and China working on the development and commercialization of immune-based therapies for patients.
Zenas is advancing a pipeline of therapeutics to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases.