BOSTON--(BUSINESS WIRE)--The FDA’s Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program issued a Letter of Support to sRNAlytics encouraging the use and development of the sRNA-FIND platform, and a biomarker panel it discovered, that monitors Huntington’s disease progression 20 years before symptomatic onset.
Current drug programs targeting Huntington’s disease utilize subjective measures to evaluate a patient’s overall physical and neurological health to measure efficacy. However, symptoms such as motor and cognitive impairment can vary from day-to-day. “The use of objective biomarkers to assess Huntington’s Disease in clinical trials will enable us to more accurately determine if treatments are effective. sRNAlytics’ discovery of an objective biomarker will help transform the way we think about therapeutic development and treating patients,” said Dr. Blair Leavitt, Professor at the University of British Columbia.
In this recent study, sRNAlytics used their sRNA-FIND platform to discover small RNA biomarkers in the brain tissue of deceased Huntington’s patients. In collaboration with researchers at the Boston University Medical School, they showed that these biomarkers could monitor Huntington’s disease progression 20 years prior to symptomatic onset in a liquid biopsy. Additional work showed correlations with neuronal cell death and loss of motor functions in patients. Dr. Richard Myers, a Professor of Neurology and study lead commented: “The small RNA profiles that sRNAlytics identified represent the most promising approach to test efficacy that I have seen to date. The FDA’s recognition of these findings is an important step forward in validating their technology and accelerating their future use in clinical trials.”
sRNAlytics is initiating partnerships with Huntington’s drug developers to identify new efficacy and patient selection markers using sRNA-FIND. “Receiving the Letter of Support is a major milestone in the development of our platform. In a few years, we’ll be able to look back and know that we played a role in delivering game-changing therapies for patients,” said Dr. David W. Salzman, the company’s CEO.
sRNA-FIND is an AI-powered, computational platform that analyzes small RNA sequencing data to uncover new insights around the genes and molecular pathways driving disease. The platform includes a proprietary suite of algorithms that have cataloged over 4.2 million small RNAs used to fuel its strong power to discover. One of the outputs of sRNA-FIND are biomarkers that translate across species and biological matrixes and can be tracked as they move from a diseased tissue into the periphery via exosomes. Applications of sRNA-FIND have been validated across CNS, Oncology and Immunology disease areas.
sRNAlytics is at the forefront of small RNA research. They offer technology and services to drug developers to facilitate drug discovery and development by providing deep analysis of disease pathways within a drug’s mechanism of action. Their analytical approach and lab protocols combined with sRNA-FIND and a growing database of over 15,000 patient samples is focused on accelerating their partners’ programs.