|title||SK Biopharmaceuticals to Initiate Phase 2 Trials in US|
Seoul, Korea, and Fair Lawn, New Jersey —SK Biopharmaceuticals, a South Korean pharmaceutical company, announced today that the first patient was dosed in a phase 2 clinical trial in the US for patients suffering with chronic constipation using their new chemical entity YKP10811. The goal of this program is to develop a drug with once-a-day oral dosing and improved efficacy and safety for the treatment of chronic constipation and other disorders related to reduced gastrointestinal (GI) motility. Recently, SK Biopharmaceuticals successfully completed their Phase 1 trials in the US.
Chronic constipation is a very common gastrointestinal disorder with a prevalence of up to 20% in the developed world. Patients with chronic constipation often experience infrequent bowel movements, hard stool and straining during defecation. The current treatment for constipation relies on dietary fiber supplements, laxatives and intestinal fluid secretagogues.
Unlike these currently-available treatment options, YKP10811 is believed to possess a broad spectrum of efficacy in both the upper and lower GI tract and an improved safety profile.
Dr. Jeong Woo Cho, Vice President of the Drug Development Business for SK Biopharmaceuticals, said, “YKP10811 was shown to be safe in Phase 1 clinical studies in healthy volunteers. In particular, the drug did not show any significant signs of adverse events.”
Dr. Christopher Gallen, CEO of SK Biopharmaceuticals, stated, “We believe that safety is the key for compounds in this class, and the innovative approach our chemists have used in developing an exceptionally clean partial agonist has great potential to produce the preclinical and clinical profile essential for a safe and effective best-in-class medication.”
If the Phase 2 clinical trials and coming Phase 3 trials are successful, it is expected that YKP10811 would be launched in 2016.
Dr. Cho also said, “Approximately 40 million Americans suffer from symptoms of abdominal pain and bloating as well the constipation that accompany chronic constipation or constipation-predominant Irritable Bowel Syndrome. At least 10 million of these patients are dissatisfied with the over-the-counter and prescription treatments that are currently available. If YKP10811 shows efficacy on the abdominal and constipation symptoms, the value of the drug will be tremendous.”
SK Biopharmaceuticals is developing the compound through its affiliate, SK Life Science, Inc., which is SK Biopharmaceutical’s U.S.A.-based business development and clinical research center located in Fair Lawn, New Jersey. Trial details may be accessed at www.clinicaltrials.gov/ct2/results?term=NCT01523184.
YKP10811 is a highly selective partial agonist at serotonin type 4 (5-HT4) receptors in the bowel. It was discovered early on to have a broad spectrum of action in animal models of gastroparesis, constipation and irritable bowel syndrome. It has an authorized Investigational New Drug status from the U.S. Food and Drug Administration.
About SK Biopharmaceuticals
SK Biopharmaceuticals is a newly-independent development-stage pharmaceutical company as of April 2011, after being spun out from SK Holdings, the third-largest conglomerate in South Korea. SK Biopharmaceuticals focuses on discovery and development of new drugs as well as providing custom services for the manufacture and sales of active pharmaceutical ingredients in addition to intermediates of drugs for other major pharmaceutical companies.
SK Biopharmaceuticals, through its affiliate SK Life Science, leads all Korean pharmaceutical companies with 13 authorized INDs in the U.S. Among compounds in current clinical development are YKP3089 in Phase 2b trials for the treatment of epilepsy and neuropathic pain and SKL11197 in a Phase 2a trial for the treatment of neuropathic pain. In February, YKP3089 was selected for funding by the Korea Drug Development Fund. SK Biopharmaceuticals intends to file INDs later this year for two additional compounds, one for the treatment of Alzheimer’s disease and one for neuropathic pain; both of these compounds are first-in-class candidates acting via new mechanisms of action.
In parallel with its internal development, SK Biopharmaceuticals has adopted a strategy of collaboration with partners to accelerate drug discovery and development. Its current partners include Neuronex with diazepam nasal spray for the treatment of acute repetitive seizures, Aerial Biopharma with SKL-N05 for the treatment of narcolepsy, Medicilon with SKL-PSY for bipolar disorder, and the Mayo Clinic to identify molecules that interact with the TDP-43 protein in amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease).
The Drug Development Business division of SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, and SK Life Science, 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, irritable bowel syndrome, and Parkinson’s disease.
The Custom Manufacturing Service (SK CMS) is a second business division of SK Biopharmaceuticals; it generated $40 million last year in the production of Active Pharmaceutical Ingredients for other pharmaceutical company customers. These customers have recognized the quality of the products and the operational efficiency provided by the Korean FDA-approved manufacturing facility in Daejeon, Korea. This facility is fully automated and is used to conduct technologies proprietary to SK Biopharmaceuticals, such as continuous flow synthesis, low temperature reactions, and catalytic conversions, that differentiate the company from other chemical suppliers.
For more information, visit www.skbp.com
SK Life Science, Inc.
Duncan Taylor, 201-421-3842