Small Biz Grant Supports Regenerative Alzheimer’s Treatment

Healthy neuron illustration (NIH, Flickr. https://flic.kr/p/CW1m6P)

13 Sept. 2023. A new award from National Institutes of Health funds preclinical work to prepare for a clinical trial assessing a treatment to reverse brain signaling damage in people with Alzheimer’s disease. The $3 million grant from National Institute on Aging, an agency of NIH, funds the two-year program advancing an experimental drug made by Spinogenix Inc. in San Diego.

Spinogenix, founded in 2016, discovers compounds for restoring functions of synapses, the electro-chemical signaling components of neurons in the brain, damaged by neurodegenerative diseases. The company says its lead product code-named SPG302 is an oral drug derived from benzothiazole, a common pharmaceutical and industrial chemical. In an earlier preclinical study, researchers from Spinogenix and university labs found SPG302 increases the density and protein expression of synapses, as well as cognitive functions in lab mice induced with neurodegenerative conditions. That team also found the changes in synapses and functions occur without affecting amyloid-beta or tau proteins on neurons associated with these disorders.

The company is testing SPG302 in an early-stage clinical trial in Australia, looking mainly for safety among healthy volunteers, but also among patients with amyotrophic lateral sclerosis or ALS. The research team is evaluating adverse effects among small numbers of healthy volunteers and ALS patients to determine safe single and multiple daily doses of SPG302, but also chemical effects in the body including concentrations of the drug in blood plasma, and interactions with food. In addition, the Australian team is measuring effects on brain activity among healthy participants, as well as respiratory and functional outcomes among ALS patients.

Reverse declines in cognitive and motor function

The National Institute on Aging award supports further preclinical research on SPG302 as a therapy to restore functioning synapses in people with Alzheimer’s disease, to prepare for an investigational new drug application with the Food and Drug Administration, in effect a request to begin clinical trials. The grant funds safety and toxicology testing of SPG302 for four weeks in lab rats and dogs, and manufacturing of SPG302 as a daily oral drug with a process that meets pharmaceutical industry standards, known as good manufacturing practice or GMP.

“Our approach is unique for diseases of the central nervous system,” says Spinogenix founder and CEO Stella Sarraf in a company statement. “SPG302 is an innovative treatment focused on regenerating synapses to reverse declines in cognitive and motor function, which is different than the many other therapeutics that are being developed for neurodegenerative conditions, which mostly aim to slow the degenerative process.”

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. Most SBIR grants are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. This is a second-phase project, with the earlier preclinical studies of SPG302 funded in part 1.

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