SciMount announces FDA approval of SMP-100's IND application for the treatment of Irritable Bowel Syndrome
CHENGDU, China, May 13, 2020 /PRNewswire/ -- 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, a wholly-owned subsidiary of Xiling Lab, 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/
SOURCE Chengdu SciMount Pharmatech, Co. Ltd.