WALTHAM, Mass and SHANGHAI, China, July 31, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global leader in immune-based therapies, has secured approval from China’s National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application. This approval allows the initiation of a Phase 1/2 clinical trial of ZB001, a novel treatment for Thyroid Eye Disease (TED), a severe autoimmune condition that can impair vision through inflammation and fibrosis around the eye.

In China, there are no approved therapies for TED, with current treatments relying on steroids, which often come with significant risks, or invasive surgery. ZB001, a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), is designed to offer a more effective treatment option.

The trial’s primary goal is to assess ZB001’s safety, tolerability, pharmacokinetics, and initial effectiveness in patients with TED. Hua Mu, MD, PhD, Chief Executive Officer of Zenas, expressed pride in the swift approval process, stating that it underscores their team’s efficiency in advancing their development plans. The company aims to collaborate with top clinical experts in China to fast-track ZB001’s development.

Zenas BioPharma licensed the exclusive rights for ZB001, also known as Viridian VRDN-001, and other IGF-1R-targeting compounds from Viridian Therapeutics for non-oncology use in the greater China region in October 2020. In the U.S., Viridian launched a Phase 1/2 trial for VRDN-001 in TED patients in December 2021 after submitting an IND to the U.S. FDA. Initial data from healthy volunteers have shown promising safety, tolerability, and strong activity in addressing TED.