Today, SciMount Pharmatech Co., Ltd. (hereinafter referred to as SciMount Pharmatech, a wholly-owned subsidiary of Xiling Lab), located in Tianfu Life Science Park, announced that the Class I new drug, SMP-100, had successfully passed the evaluation of Investigational New Drug (IND) by the Food and Drug Administration (FDA), and phase I clinical trial for irritable bowel syndrome-diarrhea (IBS-D) would be launched.

SMP-100 is the first Class 1 chemical small-molecule drug with global exclusive development and commercial rights of SciMount Pharmatech. Dr. Xie Dejian, the general manager of SciMount Pharmatech, said:

"SciMount Pharmatech is a biopharmaceutical company driven by R & D innovation and win-win cooperation, focusing on the development of innovative drugs for gastrointestinal (GI) diseases and cancer. The success of SMP-100 approved by the FDA has proved the determination and efforts in the research and development of innovative drugs, marking an important step towards becoming a new prominent of GI innovative therapy."

Dr. Xie Dejian, General Manager of SciMount Pharmatech

Irritable Bowel Syndrome (IBS) is a long-course common disorder of intestinal function, which seriously affects patients' quality of life, with bellyache, abdominal distention, accompanied by abnormal defecation and even disability. About 10-12% of adults in the world have suffered this disease. The FDA has identified IBS-D as an unmet clinical need without approved drugs for IBS-M.

5-HT3 Receptors (Picture From the Internet)

SMP-100 is the partial agonist of selective 5-hydroxytryptamine 3 (5-HT3) receptors. Different from the traditional 5-HT3 receptor antagonists, the pharmacological mechanism of carefully designed partial agonists can safely and effectively alleviate the symptoms of patients suffering IBS.

The data of preclinical study confirmed that with a clear mechanism of action, SMP-100 has high affinity and selectivity with 5-HT3 receptors, showing good oral pharmacokinetics and low interaction with other drugs. The detailed preclinical study has been published in JPET, the well-known academic journal (Click "Read More" at the end to access it).

Professor Nicholas Barnes, International renowned pharmacology and neuroscience expert, chairman of IUPHAR 5-hydroxytryptamine Receptor Naming Committee, professor of Birmingham University UK, commented:

       
"5-HT3 receptor is one of the important targets for drug development for IBS. Traditional 5-HT3 receptor antagonists will cause serious side effects, such as constipation and enteritis, which is also the reason why Alosetron is restricted in clinical treatment. Therefore, it is predicted that SMP-100 can effectively regulate 5-HT3 receptor activity, which will be superior to Alosetron with fewer side effects. With the development of SMP-100 in clinical trials, we highly expect that it will safely and effectively alleviate the pain of patients suffering IBS-D, and it is expected to become the first effective drug for the treatment of IBS-M."

About SciMount Pharmatech

SciMount Pharmatech Co., Ltd., a wholly-owned subsidiary of Xiling Lab, is committed to the development of innovative drugs for the treatment of gastrointestinal (GI) diseases and cancer, with businesses in China, the United States and Australia. With an advanced professional team and the top academic consultant team, SciMount Pharmatech has become the owner of SMP-100 and multiple pipelines of innovative drugs under development.

Source: Xiling Lab