Zenas BioPharma submits Investigational New Drug Application in China for ZB001 for the treatment of thyroid eye disease

Zenas BioPharma (USA) LLC

WALTHAM, Mass. and SHANGHAI, China, May 15, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune 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 an important milestone for Zenas,” said Hua Mu, MD, PhD, CEO of Zenas. “There are currently no approved therapies for ASD patients in China. Treatment options are limited and often involve high doses of steroids associated with serious side effects or surgery. ZB001 has the potential to change the treatment paradigm for PDD patients in China.

ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor receptor 1 (IGF-1R) for the treatment of PDD. PDD is a debilitating autoimmune disease that causes inflammation and fibrosis in the eye socket, which can lead to double vision, pain, and potential blindness. Patients with severe disease often require multiple corrective surgeries to the eye socket, eye muscles, and eyelids.

Zenas BioPharma has obtained 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 region from Viridian Therapeutics, Inc. (Viridian) in October 2020. In October 2021, Viridian submitted an IND for VRDN-001 to the United States Food and Drug Administration and, in December 2021, initiated a Phase 1/2 clinical trial to evaluate proof of concept in PDD patients in North America.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company based in the United States and China committed to becoming a leader in the development and commercialization of immune therapies for patients in the United States, China and around the world. Zenas is rapidly advancing a broad portfolio of innovative therapeutic products that continues to grow through our successful commercial development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of people facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and media contact:
Joe Farmer
Zenas BioPharma
[email protected]

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