SinoMab Cleared by China to Test Its Immunosuppressant SN1011

Phase 2/3 trial is expected to begin enrolling NMOSD patients in early 2023

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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SinoMab BioScience has been cleared by Chinese regulators to launch a clinical trial for its experimental immune-suppressing therapy SN1011 in people with neuromyelitis optica spectrum disorder (NMOSD).

The company is anticipating that the Phase 2/3 trial will begin enrolling participants in early 2023.

“The IND [investigational new drug] application of SN1011 for the treatment of NMOSD was accepted by the NMPA [National Medical Products Administration of China] at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the company’s new drug R&D program,” Shui On Leung, PhD, SinoMab’s chairman, executive director, and CEO, said in a company press release.

NMOSD is an autoimmune disease in which the body’s immune system launches an inflammatory attack that damages cells in the nervous system, ultimately resulting in disease symptoms. Immune proteins called antibodies, particularly those against the water channel protein aquaporin-4, play a central role in driving the autoimmune attack in NMOSD.

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SN1011 is designed to bind to a protein called Bruton’s tyrosine kinase, or BTK, which is critical for the inflammatory activity of B-cells, the immune cells that make antibodies. By blocking BTK, SN1011 is thought to limit the autoimmune inflammation that drives NMOSD.

While other BTK inhibitors are already used in the clinic, SN1011 binds highly selectively but reversibly to its target, which is expected to achieve superior efficacy and a good safety profile, according to the company.

SinoMab is also developing the experimental therapy for other inflammatory conditions that are characterized by out-of-control B-cell activation, including systemic lupus erythematosus (SLE), multiple sclerosis (MS), and pemphigus vulgaris (PV).

A first-in-human Phase 1 clinical trial, conducted in Australia and China from 2019 to 2021, tested SN1011 in healthy volunteers. Results showed that the experimental therapy had a good safety and pharmacological profile, according to SinoMab.

This is the fourth time the NMPA has approved an investigational new drug application for SN1011 — the agency had previously approved the initiation of clinical trials in SLE, MS, and PV. SinoMab is also planning to submit an IND in the U.S. seeking approval to start clinical testing of SN1011 in MS.

“The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor towards multiple indications in the field of the treatment of autoimmune diseases,” Leung said.