DiamiR, a developer of innovative blood-based diagnostic solutions for brain health and other indications, announced today that the National Institute on Aging (NIA) of the National Institutes of Health (NIH) has awarded the company approximately $3.36 million over two and a half years in a Commercialization Readiness Pilot (CRP) grant as part of its Small Business Innovation Research (SBIR) program. The award builds upon earlier studies conducted by DiamiR in collaboration with leading academic centers and will support late stages of development of CogniMIR™, the company's lead diagnostic product candidate for early detection and prediction of progression of mild cognitive impairment (MCI) and Alzheimer's disease (AD). CogniMIR™ combines brain-enriched and inflammation-associated microRNA biomarkers detectable in plasma with an algorithm classifier.
The second award of $498,572 over a year and a half was granted to DiamiR by the National Institute for Neurological Disorders and Stroke (NINDS) of the NIH for a project entitled "Circulating Organ-enriched microRNAs as biomarkers of Rett Syndrome." Rett syndrome (RTT) is a rare X-linked neurodevelopmental disorder caused by mutations in the MECP2 gene that affects almost exclusively females. Although diagnostic MECP2 genetic testing is available for RTT, peripheral biomarkers of RTT, including minimally invasive, blood-based indicators of disease severity and progression, are lacking. In July 2019 the initial results from DiamiR's RTT biomarker program were reported in "Brain-enriched microRNAs circulating in plasma as novel biomarkers for Rett syndrome," a paper published in PLOS ONE [https://doi.org/10.1371/journal.pone.0218623].
"We are very grateful to the NIH for their continued support for the development of our platform technology based on the targeted selection and quantitative analysis of organ-enriched, including brain-enriched, microRNAs circulating in plasma. One of the main challenges in diagnosing and treating neurodegenerative and neurodevelopmental disorders is their heterogeneity. Thus, precision medicine approaches that combine genetic, epigenetic, and other markers should prove to be most useful for better defining patient groups," said Samuil Umansky, MD, PhD, CSO of DiamiR and Principal Investigator on the grants. "Our goal is to provide drug developers and clinicians with much needed accurate and minimally-invasive diagnostic solutions early in the disease progression continuum to enable more effective therapeutic intervention and better planning of care."
"We are delighted to receive these highly competitive awards from the NIH," added Kira Sheinerman, PhD, CEO of DiamiR. "We look forward to continuing to work with our collaborators and partners in academia and industry on these two exciting programs that include prospective biomarker studies. We expect the CLIA-compliant lab-developed tests we are developing will be used initially to better define target patient groups in clinical trials, and later in broader clinical practice."
About microRNAs as biomarkers of brain health
microRNAs are small non-coding regulatory RNA molecules, which modulate gene expression and whose levels often change in disease. Certain microRNAs are enriched in different brain regions and present in synapses/neurites. microRNAs can cross the blood-brain barrier and are detectable in bodily fluids. Such microRNAs can be effective, patient-friendly biomarkers reflective of processes underlying synapse dysfunction and brain health conditions.
About DiamiR
DiamiR is a privately held molecular diagnostics company focused on developing minimally invasive tests for detection and monitoring of pathology based on quantitative analysis of organ-enriched microRNA signatures in plasma for screening, patient stratification, as well as disease progression and treatment monitoring. DiamiR collaborates with leading academic centers, disease foundations, and pharma companies. For more information, please visit the company's website at www.diamirbio.com.
