Judith Kelleher-Andersson, Ph.D., NeuroNascent President and CEO, Director
NeuroNascent Continues to See Positive Clinical Data with Alzheimer’s Therapy
The U.S. Centers for Medicare and Medicaid Services handed down judgment on the controversial Alzheimer’s drug, Aduhelm, limiting coverage of the medication only to patients who participate in clinical studies.
The decision has narrowed the treatment options for Alzheimer’s patients, who already have limited therapeutic choices. Although Aduhelm has not panned out, there are still a number of medications in clinical development for this devastating form of dementia, including Maryland’s NeuroNascent, Inc., which is developing a new chemical entity that the company hopes will be able to reverse some or all of the dreaded disease deficits, through the production of new neurons. The Rockville-based company’s lead drug candidate, NNI-362 is being developed as a potential Alzheimer’s therapy that actually preclinically demonstrated the ability to produce new neurons.
Last month, the company announced new data from a Phase 1a study, supported by the NIA, that showed NNI-362 demonstrated the ability to generate a significant reduction of an Alzheimer’s disease pathological biomarker. NeuroNascent Founder and Chief Executive Officer Judith Kelleher-Andersson said the results they are seeing offers hope as it ramps up the brain’s ability to repair or “regenerate” itself. In an interview with BioBuzz, she said the results are showing the company’s small molecule is getting through the blood-brain barrier and having an effect even with small numbers of aged subjects. NNI-362 is designed to replace neurons that are lost in the brain due to age-related neurological diseases such as Alzheimer’s.
Kelleher-Andersson explained that advances in detecting disease biomarkers of Alzheimer’s disease in plasma, such as p-tau181, enabled the company’s team of researchers to assess NNI-362’s ability to modify p-tau181 in the brain. At its two highest doses of 120 mg and 240 mg, NNI-362 was able to significantly reduce p-tau181 levels.
“This is really exciting data, it’s a really good sign,” Kelleher-Andersson told BioBuzz. “This is a nice first step to suggest eventual halt in the worsening of brain pathology.”
This shows that NNI-362 can normalize the biomarker in aged subjects, which might correlate with disease progression. She added that the use of blood biomarkers will likely enable them to expand their clinical studies in the future by finding the patients who will benefit most. Current Alzheimer’s treatments only show temporary benefits in patients. Eventually, the disease wins out and worsens, ultimately leading to death. Though NeuroNascent still must complete Phase 2 & 3 trials in AD patients, Kelleher-Andersson said NNI-362 offers some real hope for a potential paradigm shift in treating Alzheimer’s disease.
NeuroNascent’s goal is to develop NNI-362 as the first potential non-invasive, oral, neuron regenerating therapy that is able to halt or reverse Alzheimer’s and other age-related diseases progression, including Parkinson’s disease. The company’s lead drug candidate targets adult-born neuron regeneration in what Kelleher-Andersson described as a unique allosteric mechanism that has been able to turn on translation in neural progenitors in aging and neurodegenerative disorder models. At the same time, NNI-362 is also able to promote neuroprotection of these new neurons, she said.
When the company opened the blinded study, Kelleher-Andersson said they discovered that there were more minor-grade adverse events observed in subjects receiving placebo than their drug. What’s more, Kelleher-Andersson said the company is seeing the plasma biomarker reduction without having reached a maximum tolerated safety dose in the study.
Although the company posted positive data, Kelleher-Andersson said the study provided data from only a couple weeks of treatment in aged individuals. They want to conduct a study with patients for a longer period of time.
Running of a Phase 2 trial in mild to moderate Alzheimer’s disease patients could assess longer-term amelioration of p-tau181 levels and determine if this intervention could consequently improve quality of life for patient and caregiver,” Kelleher-Andersson said.
Not only does Kelleher-Andersson see the potential of NNI-362 in humans, she said the company believes a different formulation of the drug could benefit canine cognitive dysfunction. One of the benefits of promoting new neurons is that it reverses anosmia, the loss of smell.
“In most CNS disorders, you lose smell before you observe the symptoms of the disorder,” she explained. “With dogs, you can easily test smell in the animals and can use the reversal of smell as an objective means to see if new neurons are being produced and working.”
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
