The research demonstrated that treatment with FT011 results in a remarkable reversal in the activation of genetic markers associated with fibrosis FibrosisFibrosis is responsible for 45 percent of all deaths globally - FT011 is a novel drug with potential to treat chronic fibrosis in multiple organs such as the kidneys, skin, lungs, heart, and eyes Certa Therapeutics is a clinical stage biotechnology company based in Melbourne, Australia, developing innovative therapies for the treatment of fibrotic diseases ANN ARBOR, Mich. , Nov. 4, 2022 /PRNewswire/ -- New research presented today by the University of Michigan reveals ground-breaking results for Certa Therapeutics' FT011, a novel potential treatment of serious inflammatory and fibrotic diseases. The results in a chronic kidney disease (CKD) study presented at Kidney Week 2022, the annual scientific meeting of the American Society of Nephrology, concluded FT011 highly effective in reversing the activation of molecular markers associated with fibrosis[1]. Certa Therapeutics CEO, Professor Darren Kelly, one of Australia's leading life science entrepreneurs and a foremost expert in the study of fibrosis, said the results are a pivotal breakthrough in the development of treatments for fibrosis - an unmet clinical need responsible for 45 percent of all deaths globally in the industrialized world. "These findings indicate significant promise for FT011 as a potential novel therapeutic for the treatment of fibrotic diseases and support our plans to advance this investigational drug into later stage clinical trials," says Professor Kelly. "The precision and insight gained from this transformative and disruptive research could change the way we identify and treat patients with chronic kidney diseases." The data was presented by Dr Matthias Kretzler's research team. Dr Kretzler is a world-renowned nephrologist, University of Michigan Medical School Professor, and principal investigator for the Nephrotic Syndrome Study Network (NEPTUNE) – a leading research consortium of physician scientists at 26 sites in the United States and Canada which develops innovative, investigational strategies to improve the diagnosis, management and treatment of kidney diseases. NEPTUNE has recruited a prospective, longitudinal, observational cohort of more than 650 kidney disease patients with proteinuric and glomerular disease. NEPTUNE holds one of the world's largest clinical cohorts which enables analysis of clinical, histological, genetic and molecular patient information, combined with profiles of patients' long-term outcomes under standard of care. "Using this data set, there is a strong indication that treatment of patients with FT011 could mirror the positive impacts observed in the animal study in reversing the activation of molecular markers associated with fibrosis," says Dr Kretzler. "FT011 has demonstrated potential to be highly effective in the treatment of fibrotic disease. In my many decades of research, I have never seen such a significant result in our model in relation to the potential of a drug to treat fibrosis in CKD." Certa Therapeutics' fibrosis research program has been in development for over 15 years. The company has identified and understood the gene profile responsible for fibrosis, a significant scientific advancement in the study of fibrotic diseases. FT011 is a novel drug with potential to treat chronic fibrosis in multiple organs such as the kidneys, skin, lungs, heart, and eyes. "We have identified the biological receptor related to fibrosis which gives us the potential to target fibrosis in a wide range of disease states," Professor Kelly continues. "To our knowledge, there is no other drug on the market that does this." Certa Therapeutics is a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases. Certa Therapeutics has designed a platform of candidate drugs and validated the role of a novel receptor which mediates signaling pathways associated with inflammation and fibrosis. These targeted drug candidates have established proof of concept as potential treatments for multiple fibrotic diseases including serious and chronic conditions impacting the kidney, lung, eye, skin, and heart. The morbidity and mortality impact of fibrotic diseases is substantial, ultimately causing 45 percent of all deaths globally. Certa Therapeutics is seeking to combine these innovative therapeutics with biomarkers and genetic analysis to identify those patients most likely to benefit from treatment. Significant breakthroughs are urgently needed in this field, addressing a market worth more than US$15B annually. https://certatherapeutics.com/
NEPTUNE aims to understand what causes Nephrotic Syndrome (NS) and has captured information derived from clinical data, patient reported outcomes, and information from kidney biopsy tissue, blood, and urine samples. With this rich knowledge base, NEPTUNE will now transition from observing how NS impacts patients to finding new and effective ways to treat the disease. Most importantly, NEPTUNE will match the disease triggers that are active in an individual patient's kidney, to targeted clinical trials in pre-competitive partnerships with leading companies developing novel treatments for NS. [1] S Eddy, et al., "Identification of Non-Invasive Surrogates as Predictors of Response to FT011 in Kidney Disease" ASN Kidney Week 2022, abstract 3767783