Investigational Alzheimer’s Therapy NNI-362 Receives FDA Approval to Enter Phase 1 Clinical Studies

Investigational Alzheimer’s Therapy NNI-362 Receives FDA Approval to Enter Phase 1 Clinical Studies
The U.S. Food and Drug Administration has approved Neuronascent’s investigational new drug (IND) application for NNI-362, its therapy candidate for Alzheimer's disease, allowing it to move ahead with a Phase 1a clinical trial, the company announced. The first-in-human trial will evaluate the safety of NNI-362 in healthy volunteers, ages 50 to 72 years. The study, to be conducted at a single clinical site, will also assess how the therapeutic agent is absorbed, distributed, broken down, and eliminated by the body, or its pharmacokinetics. Researchers will administer single, multiple, and increasing doses of NNI-362 in approximately 56 healthy older participants. "Given the many recent disappointments in Alzheimer's trials targeting amyloid, it is essential to pursue innovative treatment targets and strategies, especially if such a treatment is a non-invasive therapy that could safely produce new neurons in aged Alzheimer's patients," R. Scott Turner, MD, PhD, clinical monitor of the trial and the director of the Memory Disorders Program at Georgetown University, said in a press release. NNI-362 is an orally available therapeutic candidate that is being developed to selectively stimulate neuronal progenitor cells to transform into fully functioning neurons through a process called neurogenesis.
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