SciMount announces FDA approval of SMP-100's IND application for the treatment of Irritable Bowel Syndrome

CHENGDU,China,May 13,2020 -- SciMount Pharmatech,Co. Ltd.,a wholly-owned subsidiary of Xiling Lab,announces today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for SMP-100 for the treatment of Irritable Bowel Syndrome with diarrhea (IBS-D).

This trial will be the first randomized,double-blinded,placebo-controlled Phase I clinical trial investigating the safety and pharmacokinetics after oral administration in healthy volunteers.

"This IND approval is an important step in SciMount's ambition to be a global leader in innovative therapeutics for the treatment of gastrointestinal diseases," said Dejian Xie,PhD,General Manager at SciMount.

IBS is a chronic and sometimes disabling bowel disorder that is often associated with severe abdominal pain. It is estimated that 10-12% of all adults are affected. There currently is no adequate treatment for IBS-D and no approved therapeutic for the treatment of IBS with alternating symptoms between diarrhea and constipation (IBS-mixed or IBS-M).

SMP-100 is a selective serotonin receptor-3 (5-HT3) partial agonist that has a large therapeutic index,appropriate evidence for a better side-effect profile,favorable pharmaceutical properties and,thus,the potential to treat a wider spectrum of IBS-D and IBS-M patients. The detailed pharmacological profile for SMP-100 was recently published in a leading,peer-reviewed pharmacology journal,which can be accessed here: http://jpet.aspetjournals.org/content/373/1/122.long.

Professor Nicholas Barnes (Chair of the IUPHAR 5-HT receptor nomenclature committee and Professor of Pharmacology; www.linkedin.com/in/nicholasmbarnes/) added:"The 5-HT3 receptor is a proven target to deliver major benefit to patients with IBS-D. Unfortunately,it appears that too high a level of 5-HT3 receptor inhibition results in side-effects that limit the use of 5-HT3 receptor antagonists like alosetron. Elucidation of the pharmacological signaling allowed informed selection of SMP-100 as the drug candidate predicted to be superior to alosetron by replicating its clinical efficacy with reduced side-effects. As SMP-100 now moves into clinical trials we are excited about the potential to relieve the suffering of patients with IBS-D and perhaps IBS-M."

About SciMount Pharmatech,Co. Ltd.

SciMount,is a clinical-stage drug development company with operations in China,US and Australia,focusing on the discovery of innovative medicines for the treatment of GI diseases and cancer. The company's pipeline includes SMP-100 and other innovative discovery stage projects.http://www.xilinglab.com/en/

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