SK Biopharmaceuticals to Initiate Phase 2 Trials in US

Business Wire – February 21, 2012 07:55 PM.

SEOUL, South Korea–(BUSINESS WIRE)–South Korean pharmaceutical company SK Biopharmaceuticals announced yesterday that they have initiated a phase 2 trial in the US for patients suffering with diabetic peripheral neuropathy using their new chemical entity SKL11197. Recently, SK Biopharmaceuticals successfully completed their phase I trials in the US.

Diabetic peripheral neuropathy is a form of neuropathic pain; this pain is known to occur from damage to terminal nerves in the periphery or dysfunction of those nerves; this pain is frequently so severe that it makes normal daily life unbearable.

Unlike many other drugs that are currently marketed for the treatment of neuropathic pain that were originally developed for the treatment of epilepsy or depression, SKL11197 has been developed solely for the treatment of pain.

Dr. Jeong Woo Cho, Vice President of the Drug Development Business for SK Biopharmaceuticals, said, “SKL11197 was proven to be safe in Phase 1 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.”

If the Phase 2 clinical trials and coming Phase 3 trials are successful, it is expected that SKL11197 would be launched in 2018.

Dr. Cho also stated, “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 2 clinical trials for the treatment of pain due to osteoarthritis. The worldwide neuropathic pain market is $2.5 billion in size, and if SKL11197 shows efficacy in various type of pain, the value of the drug will be tremendous.” Read more