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, at the highest tested dose level of 1,350 mg, the drug did not show any significant signs of drowsiness or sedation."