The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma.
SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.
It can suppress Th2 immune responses by binding to IL-17RB on Type 2 innate lymphoid cells (ILC2s).
This blocks a cascade of responses that are induced by interleukin-25 (IL-25), a critical cytokine which is classified as ‘alarmin’.
SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.
In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma.
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The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.
SinoMab BioScience executive director, chairman and CEO Dr Shui On LEUNG stated: “The number of asthma patients worldwide has increased year by year, the existing therapies have not fully met the medical needs and there is still a huge gap in effective treatment of severe asthma.
“As the world’s first humanised IgG4-κ monoclonal antibody targeting IL-17RB, SM17 has made satisfactory progress in clinical research under the active promotion of the company.
“The acceptance of the IND application for SM17 not only accelerated the company’s clinical development project for the treatment of asthma indications in China, but also demonstrated the high efficiency of our new drug development.
“It is expected that this new treatment option will benefit more Chinese patients in the future and bring a promising treatment for severe asthma patients.”