The Korea-based international pharmaceutical company, SK Biopharmaceuticals, announced that they entered into a co-development agreement with SK Chemicals for its novel new small molecule YKP10811 that is being developed for the treatment of irritable bowel syndrome with constipation (IBS-C).
Both companies are part of the SK Group, the third largest conglomerate in Korea. SK Chemicals established itself as a leading pharmaceuticals franchise for the treatment of gastrointestinal diseases that includes such important products as Levopride®, to control gastrointestinal tract movement, and Omed®, a new formulation for gastritis.
As part of this agreement, SK Chemicals will conduct later-stage clinical phase 2 and 3 trials in Korea for an expected launch in 2018. SK Chemicals will have marketing rights in Korea. SK Biopharmaceuticals will develop YKP10811 in the rest of the world for all applicable indications.
Dr. Christopher Gallen, CEO and President of SK Biopharmaceuticals, said, “This alliance creates a valuable synergy within the SK Group to enhance the opportunity for YKP10811 to treat multiple diseases of the enteric nervous system, Chronic Idiopathic Constipation as well as IBS-C. We will continue to discover and develop novel drugs in central, peripheral, and enteric nervous systems to create a better future for patients suffering from these serious disorders. The world needs better treatments for nervous system diseases, and we are working hard to create and develop them.”
A Phase 1 study in the U.S. demonstrated sufficient safety and tolerability in healthy volunteers to proceed in development. SK Biopharmaceuticals is sponsoring a Phase 2 proof of concept trial that is being conducted at the Mayo Clinic to evaluate the effects of the drug on gastric and colonic transit in patients with chronic idiopathic constipation.
YKP10811, awarded funding from the Korea Drug Development Fund in December 2012, 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 models of abdominal pain, and its Investigational New Drug status was authorized by the U.S. Food and Drug Administration in 2009.
The Korea Drug Development 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. Its objective is to develop at least ten new drugs by 2020.