AsianScientist (Feb. 29, 2012) – South Korean pharmaceutical company SK Biopharmaceuticals has initiated a Phase II trial in the United States for its new diabetic peripheral neuropathy drug, SKL11197. The company recently concluded Phase I trials for SKL11197 in the U.S.
Diabetic peripheral neuropathy is a form of debilitating neuropathic pain from damage to terminal nerves in the periphery, or dysfunction of those nerves.
Unlike many other drugs marketed for the relief of neuropathic pain that were originally developed to treat epilepsy or depression, SKL11197 has been developed solely for the treatment of pain.
“SKL11197 was proven to be safe in Phase I clinical studies investigating its safety 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,” said Dr. Jeong Woo Cho, VP of the Drug Development Business for SK Biopharmaceuticals.
If the Phase II clinical trials and upcoming Phase III trials are successful, it is expected that SKL11197 would be launched in 2018.
“SKL11197 also has effects against various other types of pain and in animal models of anxiety and depression. SK Biopharmaceuticals is planning for additional Phase II clinical trials for the treatment of pain due to osteoarthritis,” said Dr. Cho.
According to Cho, the global neuropathic pain market is worth an estimated US$2.5 billion, and if SKL11197 shows efficacy in various type of pain, the value of the drug will be significant.
The compound is being developed independently through its affiliate, SK Life Science, Inc., which is SK Biopharmaceutical’s U.S.-based business development and clinical research center located in Fair Lawn, New Jersey.
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Source: SKBP.
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