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news.The FDA has approved the start of human trials for an oral compound for the treatment of Alzheimer's disease being developed in a collaboration between Humanetics Corporation and Mount Sinai School of Medicine.
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Phase I and phase II studies of the compound, NIC5-15, in a population of early stage Alzheimer’s disease patients will now be immediately advanced by Mount Sinai School of Medicine (MSSM).
“We are pleased that FDA has approved the start of clinical trials for NIC5-15,” said Ronald Zenk, president and CEO of Humanetics. “NIC5-15 represents the potential for a new class of compounds focused on modifying the disease itself by slowing or preventing its progression.”
In December 2005, Humanetics entered into two agreements with Mount Sinai School of Medicine connected to the development of NIC5-15. The first is a clinical research agreement which allows investigators at Mount Sinai to study Alzheimer’s patients to assess if NIC5-15 is well tolerated and to compare doses with respect to tolerability and clinical efficacy. The second provides Humanetics with exclusive rights under pending patents to commercialize products containing NIC5-15.
In the earlier preclinical studies and animal models, NIC5-15 was found to be effective in preventing the formation or slowing the progression of beta amyloid plaques, which are believed to be a cause of Alzheimer’s disease.