FAIRFIELD, N.J., Aug. 30 /PRNewswire/ -- SK Corporation (Heon-Cheol Shin, CEO and President) announced that the U.S. Food and Drug Administration (FDA) had completed its review of the Investigational New Drug Application ("IND") filed by its subsidiary, SK Bio-Pharmaceuticals, for the anxiety drug YKP3089. On August 12, 2005, the FDA acknowledged that the first clinical trial for YKP3089 using human volunteers may now be initiated. SK plans to initiate clinical testing in the U.S. in the 3rd quarter of 2005.
YKP3089 is a novel small molecule that is currently under development as an anxiolytic therapeutic agent. The exact mechanism(s) by which YKP3089 exerts its effects remain under active investigation. YKP3089 is shown to be active when administered orally with the dose-response curve using animal models for anxiety. This compound is predicted to have a favorable side effect profile when compared to the typical pharmacologic agents currently in use to treat this condition.
YKP3089 was well absorbed in test animals, displayed good microsome stability, and demonstrated good distribution with excellent mass balance recovery. The compound was negative in the gene toxicity assays. In several tests, there were no signs of cardiovascular ECG abnormality and no evidence of teratogenic potential
In addition to anxiolytic properties, this non-benzodiazepine compound demonstrates good activity in animal models for epilepsy, pain, and neuro-protection. SK Corporation anticipates YKP3089 will differentiate itself from current treatments by displaying less side effect potential and broader indication spectrum.
Dr. Yong Moon Choi (Executive V.P.), the head of SK Bio-Pharm Business, states the IND approval is the result of the long-term commitment and support of SK Corporation and the continuous efforts contributed by its researchers.
YKP3089 is the fourth IND for SK Bio-Pharmaceuticals. Previously approved IND's are YKP10A for depression, YKP509 for anti-epileptic indication, and YKP1358 for schizophrenia.
Anxiety disorders are common and disabling. These disorders generally fall into five main categories that include panic disorder, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder and posttraumatic stress disorder, each of which has characteristic symptoms. These disorders are among the most prevalent psychiatric disorders in the general population, found nearly twice as often in women, and are estimated to affect 26.9 million individuals in the United States alone.
Through its subsidiary SK Bio-Pharmaceuticals, SK Corporation, a leading energy and chemical company in Korea, has been engaged in the innovative discovery of novel therapeutic compounds in the field of neuroscience in order to treat problems of epilepsy, depression, anxiety, Parkinson's, anti-psychotic and neurodegenerative disorders. In addition to the CNS area of research, SK Bio-Pharmaceuticals is working in the discovery of novel therapeutic compounds in the area of cancer and metabolic disease.
About SK Bio-Pharmaceuticals
SK Bio-Pharmaceuticals (SKBP) is a wholly owned subsidiary of SK Corporation. SKBP and its parent company are two of the 40 plus member companies that comprise SK Group, the third largest conglomerate in Korea. Having advanced into development of new drugs in 1993, SKBP became the first Korean company to obtain IND approval from the US FDA three years later. SKBP is a truly globalized Pharmaceutical R&D company, with operations in the U.S., Korea, and China.
SKBP proved its world-class capability of new drug development, obtaining 4 consecutive IND approvals in the CNS area. SKBP extends its research beyond the CNS area into treatment for metabolic diseases, cancer and drug delivery system. SKBP bolster its product pipeline portfolio fully utilizing the R&D network established in the U.S., Korea and China.
Currently, SKBP focuses its resources on laying the groundwork for establishment of RPM (Research, Production, and Marketing) integration. As showcased in its development of new drugs, SKBP is committed to opening the sound future for humankind generating future value.
SK Bio-Pharmaceuticals