FDA authorizes SK Biopharmaceuticals' IND application for SKL15508 to treat CIAS

The Korea-based international pharmaceutical company, SK Biopharmaceuticals, announced today 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).

SK Biopharmaceuticals has developed this novel drug since 2007, taking the approach that while the existing drugs treat schizophrenia by reducing positive and, in some cases, negative symptoms of the disease, they have little effect on the cognitive impairment that so frequently disrupts the lives of its sufferers.

SKL15508 potently relieves the signs of cognitive impairment in animal models with a very large safety margin. In addition, when administered with currently available drugs, SKL15508 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.

Dr. Christopher Gallen, CEO and President of SK Biopharmaceuticals, said, "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."

SOURCE SK Biopharmaceuticals