DiamiR said today it has won a three-year, $2.75 million Small Business Innovation Research (SBIR) Phase IIB grant from the NIH’s National Institute on Aging (NIA) toward accelerating development of its Alzheimer’s disease diagnostic.
DiamiR’s CogniMIR test is designed to detect Alzheimer's at the presymptomatic, mild cognitive impairment and dementia stages through analysis of brain-enriched microRNA biomarkers in plasma.
“Initially, we expect that the test will contribute to the characterization of heterogeneous populations of early-stage Alzheimer's patients in clinical trials,” DiamiR CEO Kira Sheinerman, Ph.D., said in a statement. “In the long term, the test, along with other diagnostic tools, could be used by the broader medical and scientific community to evaluate at- risk populations, monitor disease progression, and plan better care.”
The CogniMIR development program has received earlier SBIR funding consisting of a $225,000 Phase I grant that was announced in June, followed by a $1.5 million Phase II grant. The company said the program builds upon earlier studies it conducted with “leading” academic centers.
Also among DiamiR’s collaboration partners is Johnson & Johnson’s Janssen Pharmaceuticals, which is partnering with the molecular diagnostics developer to study how DiamiR technology can be used in the context of clinical development of a therapeutic agent for treatment of neurodegenerative disease indications. The partners signed a research collaboration agreement facilitated by Johnson & Johnson Innovation.
DiamiR reasons that brain-enriched microRNAs, present in synapses and detectable in plasma, can be effective and patient-friendly biomarkers, reflective of processes that underlie brain health conditions. Synapse dysfunction and/or loss occurs early in the development of many neurodegenerative diseases, while the blood-brain barrier can be crossed by microRNAs. Some microRNAs are enriched in different brain regions, such as the hippocampus and midbrain; while others are enriched in cells such as neurons; and still others, in portions of the cell, such as synapses and neurites.
In addition to CogniMIR, DiamiR’s pipeline includes tests for mild cognitive impairment progression to Alzheimer’s, Parkinson’s disease, frontotemporal degeneration, and amyotrophic lateral sclerosis (ALS).
“Our novel, blood-based diagnostic approach focuses on detecting changes in the synaptic health of the specific brain regions affected by the disease, with the goal of identifying patients earlier, preferably before they exhibit clinical symptoms, when treatment can be more effective,” DiamiR CSO Samuil Umansky, M.D., Ph.D., said in a statement.
Privately-held DiamiR, a wholly-owned subsidiary of DiamiR Biosciences, focuses on developing minimally-invasive molecular diagnostics for early detection and monitoring of conditions that include Alzheimer’s and mild cognitive impairment. The company’s proprietary technology is based on quantitative analysis of organ-enriched microRNA signatures in plasma and is being developed for disease progression and treatment monitoring, as well as screening and patient stratification.