SEOUL, South Korea--(BUSINESS WIRE)--The South Korean pharmaceutical company, SK Biopharmaceuticals, announced that YKP10811, for the treatment of chronic idiopathic constipation, has been awarded funding from the Korea Drug Development Fund to support clinical development for the next two years. An agreement between the two parties was signed on December 13.
“YKP10811 has outstanding effects on bowel movements and abdominal pain caused by chronic constipation. If YKP10811 shows efficacy on the abdominal and constipation symptoms, we could create a great milestone for the treatment of functional gastrointestinal disorders such as chronic constipation and constipation predominant irritable bowel syndrome.”
SK Biopharmaceuticals becomes the only company which has multiple granted projects - YKP3089, for the treatment of refractory epilepsy, and YKP10811, for the treatment of chronic idiopathic constipation - from the Korea Drug Development Fund.
The Korea Drug Development Fund was established in September 2011 with assets of $1 billion to develop at least ten new drugs by 2020. The fund is a consortium of three health-related Korean ministries, the Ministry of Knowledge Economy, the Ministry of Education, Science and Technology, and the Ministry of Health and Welfare.
YKP10811 is the lead molecule in SK Biopharmaceuticals’ pipeline. The funding support received will be used to support global late Phase 2 clinical trials in chronic idiopathic constipation.
Dr. Christopher Gallen, CEO of SK Biopharmaceuticals, said, “The selection of YKP10811 by the Korea Drug Development Fund is an acknowledgement from the Korean government of the drug’s potential to become a global blockbuster as well as the innovation and competitiveness of SKBP’s R&D. If our Phase 2 and Phase 3 clinical trials go smoothly, we will be able to market the drug in 2016.”
And Dr. Jeong Woo Cho, COO of SK Biopharmaceuticals, said, “YKP10811 has outstanding effects on bowel movements and abdominal pain caused by chronic constipation. If YKP10811 shows efficacy on the abdominal and constipation symptoms, we could create a great milestone for the treatment of functional gastrointestinal disorders such as chronic constipation and constipation predominant irritable bowel syndrome.”
About Chronic Idiopathic Constipation
According to a report from Timely Data Resources, Inc, chronic idiopathic constipation affects approximately 14% of the world’s population, or 700 million people worldwide, making it one of the most common gastrointestinal diseases. This report estimates that 30 million Americans are affected by chronic idiopathic constipation. Chronic idiopathic constipation is a condition that makes bowel movements difficult or irregular and may be caused by a malfunction of the large intestine or of the defecation process.
YKP10811 was discovered early on to have a broad spectrum of action in animal models of upper and lower gastrointestinal disorders. It is also active in abdominal pain models, and its Investigational New Drug status was authorized by the U.S. Food and Drug Administration in 2009. A Phase 1 study in the U.S. demonstrated sufficient safety and tolerability in healthy volunteers to proceed in development. A Phase 2 proof of concept trial has been initiated to evaluate the effects of the drug on gastric and colonic transit in patients with chronic idiopathic constipation.
About SK Biopharmaceuticals
SK Biopharmaceuticals is a newly-independent development-stage pharmaceutical company after being spun out in April 2011 from SK Holdings, the third-largest conglomerate in South Korea. SK Biopharmaceuticals focuses on discovery and development of new drugs treating central nervous system disorders. SK Biopharmaceuticals also provides custom services for the manufacture and sales of active pharmaceutical ingredients as well as produces intermediates of drugs for global pharmaceutical companies at its facility in Daejeon, South Korea. The plant has been newly approved in Korea for the production of active pharmaceutical ingredients under current Good Manufacturing Practices.
SK Biopharmaceuticals leads all Korean pharmaceutical companies with 13 authorized INDs in the U.S. SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, corporate offices in Seoul, South Korea, commercial and partnering offices in Shanghai, China, and its business development and clinical research center in New Jersey for the clinical development of its assets in the areas of epilepsy, neuropathic pain, depression, chronic constipation, Parkinson’s disease, and Alzheimer’s disease.
For more information, visit www.skbp.com.