Chinese Authorities Approve Trial of SN1011; US Study on Horizon

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by Lindsey Shapiro, PhD |

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The National Medical Products Administration (NMPA) of China has agreed to approve a Phase 2 trial testing the safety and efficacy of the investigational therapy SN1011 in people with multiple sclerosis (MS).

SN1011 is being developed by SinoMab Bioscience to treat a range of autoimmune and inflammatory conditions.

The Hong Kong-based biotech company plans to soon submit a similar investigational new drug (IND) application for a clinical trial in the U.S. If U.S. regulators approve that request, SinoMab hopes a global Phase 2 trial will be launched in the third quarter of this year. Meanwhile, enrollment of the first patient in the Chinese trial is planned for the end of the year.

“The IND application for MS for SN1011 was accepted by the NMPA at the beginning of the year, and was approved only three months later, which fully reflects the NMPA’s recognition of the company’s candidate products, and also confirms the efficient execution of the company’s new drug R&D program,” Shui On Leung, PhD, chairman, executive director, and CEO of SinoMab, said in a press release.

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An enzyme called Bruton’s tyrosine kinase or BTK is involved in the activation of B-cells — an immune cell type known to drive the excessive and aberrant immune attacks that damage the nervous system in MS.

SN1011 is designed to block BTK, thus targeting the harmful B-cells. It is thought that in doing so, it can prevent inflammation and delay disease progression.

The first in-human clinical study of SN1011 was a Phase 1 trial conducted in Australia (NCT04041544). That trial, with an estimated enrollment of 80 healthy adults, evaluated the safety and pharmacokinetics of single and multiple doses of SN1011 compared with a placebo. Pharmacokinetics assesses how a medication moves into, through, and out of the body.

Taken orally, SN1011 was administered at doses ranging from 25–200 mg once per day, or 100 mg twice per day.

According to SinoMab, results showed that SN1011 had a favorable safety and pharmacokinetic profile.

The NMPA also has OK’d INDs for Phase 2 trials of SN1011 in systemic lupus erythematosus, known as SLE, and pemphigus vulgaris (PV), two other autoimmune conditions.

“The approval of this IND application is the third indication of SN1011 in China following the approval of IND application for SLE and pemphigus, fully demonstrating the great potential of our innovative BTK inhibitor in the field of the treatment of autoimmune diseases,” Leung said.

Several other BTK inhibitors are currently under development as potential MS treatments, including EMD Serono’s evobrutinib, Roche’s fenebrutinib, and Sanofi’s ibrutinib. Most are now in Phase 3 trials.

SinoMab believes that SN1011 has a unique mechanism of action that will grant it greater selectivity, safety, and efficacy compared with existing BTK inhibitors.

“We are absolutely confident in the enormous prospects of SN1011’s clinical development, we will also accelerate clinical trials and continuously expand the scope of potential indications,” Leung said.

“In the future, we will accelerate our R&D projects implementation,” Leung added, noting that the company planned to “devote to the vision of independent innovation, further expand the product portfolio and potential indications, dedicate to exploring safe and effective treatments for patients suffering from autoimmune diseases worldwide.”

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