Trials approved for drug to treat CIAS

SEOUL – Korean pharmaceutical company, SK Biopharmaceuticals, said the U.S. Food and Drug Administration (FDA) has authorized the Investigational New Drug (IND) application for SKL15508 to treat cognitive impairment associated with schizophrenia (CIAS).

SKL15508 potently relieves the signs of cognitive impairment in animal models with a very large safety margin. When administered with currently available drugs, this novel demonstrates synergistic effects that are expected to improve overall symptoms in patients while minimizing side effects.

SK Biopharmaceuticals will initiate global clinical trials of SKL15508 this year. Expansion into other cognitive impairment disorders, such as Alzheimer’s disease, is under consideration by the company.

“This is the fourteenth IND approval for SK Biopharmaceuticals. 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.”

“This is the fourteenth IND approval for SK Biopharmaceuticals,” said Dr Christopher Gallen, CEO and president of SK Biopharmaceuticals. “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.”

Over 50 million patients are suffering from schizophrenia, and the number of patients is increasing in developed societies. The global market size of antipsychotics is estimated to be worth about $50 billion and $70 billion in 2012 and 2021, respectively.