Kainos Medicine said Friday it has completed the administration of a human immunodeficiency virus (HIV) treatment, KM-023, to Chinese patients in 48-week double-blind phase 3 trials.
Jiangsu Aidea Pharmaceuticals of China conducted a statistical analysis of its efficacy and decided to begin working on a document for the new drug application (NDA) during an open follow-up period this summer to shorten the final approval process.
That will put Kainos Medicine a step closer toward commercializing KM-023, the Korean company said.
Kainos Medicine, a developer of treatments for CNS (central nervous system) diseases, transferred the technology of KM-023 to Jiangsu Aidea Pharmaceuticals in 2014. China’s National Medical Products Administration picked KM-023 as a drug for fast track review in 2017, and the clinical development is making swift progress.
The Korean company said that expectations are rising for the safety of KM-023, as the share of dropouts due to side effects is lower than that of competing drugs during the phase 3 trials.
Jiangsu Aidea also anticipates KM-023 will replace existing drugs such as Efavirenz and Rilpivirin because of its potency and safety. The Chinese company has the sales rights of the drug in China, and Kainos Medicine has the rights for the global market.
“We are looking forward to seeing Jiangsu Aidea’s quick NDA paperwork,” a Kainos Medicine official said. “The company plans to enter emerging markets based on joint clinical data.”
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