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Autism spectrum disorders (ASD) are a complex group of neurodevelopmental disorders characterized by repetitive specific behavioral patterns and significant difficulties in social communication and interaction. These symptoms usually appear in early childhood and have a significant impact on a patient's daily functioning. The term "spectrum" reflects the diversity of symptoms, skill differences, and degree of functional disability among people with ASD. Some children and adults with autism spectrum disorders have the ability to perform activities of daily living independently, while others require extensive support to perform basic activities.

In the United States, the prevalence of autism is as high as 2.7%, or 1 in 36 children. In China, there are more than 10 million people with autism spectrum disorder, including about 3 million to 5 million children aged 0-14. At present, applied behavior Analysis therapy (ABA) is the most widely used and well-studied treatment for autism. The therapy helps patients learn new skills and reduce bad behaviors by analyzing and shaping their behaviors and using positive and negative reinforcement. However, there are currently no specific drugs that can completely cure autism. Psychotropic drugs such as risperidone, fluoxetine and methylphenidate are sometimes used to relieve symptoms such as irritability and depression, but they can have significant side effects such as drowsiness and headaches.

Scientific research in recent years has found that autistic people generally have a lower diversity of gut microbiota than healthy people. Among them, "gut-brain axis" plays an important role in this process. The gut flora can communicate bidirectionally with the brain through the gut-brain axis, and the neuroactive substances, metabolites and immune signals produced by them can affect the development and function of the brain through neural, endocrine and immune pathways. Changes in the gut microbiota of people with autism may lead to abnormal serotonin levels, which in turn affect nervous system function.

Through cohort studies, the scientists found that in people with autism, which is partly caused by genetic factors, there is a positive feedback mechanism between the gut microbiome and the host immune system, and once one party is dysfunctional, the whole system deteriorates. Based on this, LS-LBP-002 focuses on the flora combination with Lactobacillus plantarum as the core. This bacterial community combination can produce short chain fatty acids such as butyric acid and other metabolites, which can inhibit the activity of histone deacetylase, increase the level of histone acetylation, and then increase the accessibility of genes, promote the expression of related genes, regulate the normal expression of related genes such as neurodevelopment and neurotransmitter metabolism, and thus alleviate autism-related symptoms. The pipeline is expected to become a living biologic breakthrough therapy for ASD, qualifying for FDA Phase 3 clinical trial exemption.