Neuronascent lands NIA grant to advance Alzheimer’s treatment to Phase 2 clinical trials

Neuron regeneration company Neuronascent has been granted a U01 award by the National Institute of Aging (NIA) to advance its investigational drug, NNI-362, into Phase 2 clinical trials for mild to moderate Alzheimer’s disease.

The grant will enable Neuronascent to conduct long-term safety testing and GMP manufacture of NNI-362. The testing is essential before proceeding with a trial to assess if NNI-362 can halt and potentially reverse the disease’s progression, improving memory and executive function in patients.

“There is still a need for therapies to actually halt and potentially reverse the disease at the next stage of disease progression from pre-AD to severe AD,” said Dr R Scott Turner, Professor of Neurology at Georgetown University.

NNI-362 is Neuronascent’s lead investigational therapy and is designed to combat age-related disorders by generating new neurons to replace those lost in chronic neurodegenerative conditions associated with aging. Administered orally, the treatment has successfully completed a Phase 1a clinical trial supported by NIA and approved by the FDA, which assessed the treatment’s safety, pharmacokinetics, and its effect on a plasma biomarker indicative of Alzheimer’s disease progression.

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NNI-362 was discovered through a screening program designed to identify small molecules capable of entering the human brain and stimulating the growth of new adult-born neurons. The experimental therapy targets p70S6 kinase, a regulator of cell cycle progression, through a unique allosteric modulation mechanism, which sets it apart from conventional kinase inhibitors and addresses safety concerns associated with them.

Beyond Alzheimer’s disease, Neuronascent anticipates that NNI-362 could provide benefits for various age-related disorders stemming from the loss of adult-born neurons in cognitive and motor regions of the brain.

“With therapeutics that address the different stages of disease, we may finally be at the point of obtaining precision medicine for age-related neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease,” said Dr Judith Kelleher-Andersson, CEO of Neuronascent.