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How does Ignite Biomedical's TNFi Treatment Response Predictor (TRP) address the current inefficiencies in TNF-alpha inhibitor therapy?
Published data shows that only about 30% of patients initiated on TNFi therapy achieve an expected clinical response leaving the 70% that do not respond to therapy experiencing unnecessary adverse events and irreversible disease progression. In a drug class that is costing healthcare in the U.S. ~$30 Billion each year this test will also remove a tremendous amount of waste from our system.
What is the market potential for Ignite Biomedical's precision medicine solutions, particularly with the TNFi test?
Precision medicine is estimated to be a $700 billion dollar market in 5-6 years. Our TNFi test alone presents an immense opportunity for Ignite as we plan to develop this asset across all 9 diseases where TNFi therapy is indicated, with Inflammatory Bowel Disease being the first. In addition, we plan to build out our Immunology portfolio and commercialize treatment response predictors across the first 3-6 lines of therapy in each condition. We also plan to expand to areas of Behavioral Medicine and Neurology (Alzheimer's and Parkinson’s Disease).
How does Ignite Biomedical's AI-driven approach differentiate it from other biomarker discovery companies in the precision medicine space?
Our approach first brings world renowned clinical experts to inform the discovery process with our JV partner Liquid Biosciences. This is not to formulate hypotheses but instead to identify the problem(s) facing each therapy or condition. The AI model is not informed by any preconceived thoughts or published information. This is done to avoid the injection of bias, allowing the model to inform us objectively and quantitatively to what associations exist. Once the discovery work is done we reconvene to share the results and agree on a product development path. Most other, if not all, AI applications today inform the model with published biomarker information and test for an association. Unfortunately, this only increases the rate of bias and provides no solution to the relationship of the relevant biomarkers to themselves in connection with the outcome of interest. Our AI process is 100% reproducible and may be applied to any disease or question. It produces extremely accurate results quickly with minimal bias that can be effectively translated into clinical scale tests in the real world.
What are the key milestones in Ignite Biomedical's clinical development pipeline following the successful analytical validation of the TNFi TRP?
We are in the process of staging and funding our Clinical Validation (CV) Study for the TNFi TRP on IBD. This will be the first indication with Rheumatoid Arthritis, Psoriasis, and Psoriatic Arthritis to follow. Once our CV is complete we can begin the process of initial approval with a granted CPT reimbursement code. This event is approximately 2 years away.
How does Ignite Biomedical plan to commercialize its Treatment Response Predictors and generate revenue?
Our approach will incorporate a combination of direct distribution/testing through our lab SmartHealth Diagnostics and direct licensing to established national lab companies, as well as local hospitals/clinics/systems that fall outside this established network. Our goal is to have as open a network as possible so every physician and patient has access to utilize our test(s).