Certa Therapeutics' investigational drug FT011 delivers breakthrough results as a potential novel treatment for serious inflammatory and fibrotic diseases

• Research presented today by University of Michigan Medical School highlights FT011's ground-breaking treatment potential from human expression profiles in chronic kidney disease study supported by animal model data
• The research demonstrated that treatment with FT011 results in a remarkable reversal in the activation of genetic markers associated with fibrosis
• Fibrosis 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."

Comparative transcriptomic analysis with human kidney data identified potential predictive clinical and biomarker profiles of patients most likely to respond to FT011 treatment for advanced kidney diseases, including Focal Segmental Glomerulosclerosis (FSGS) and Membranous Nephropathy (MN). This analogous pattern of elevated gene activation is also present in an animal model of chronic kidney disease. Research showed that treatment with FT011 over 12 weeks in this model significantly reduced the fibrosis-associated gene response characteristic of the human disease. Consequently, the study indicates a likely positive response in human 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."

Top line data from Certa Therapeutics' phase II trial in scleroderma patients is expected to be released in early 2023.

About Certa Therapeutics & FT011

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.

Breakthrough research conducted by Certa Therapeutics has identified a novel biologic target in the fibrosis mechanism as a defined G protein-coupled receptor (GPCR). This GPCR is silent in healthy tissue but activated following injury or disease. Evidence demonstrates the role this GPCR has on multiple downstream pathways causing inflammation and fibrosis. FT011 is a novel drug which inhibits this GPCR, offering potential to treat chronic fibrosis in multiple organs.

https://certatherapeutics.com/^[1]

University of Michigan Medical School Chronic Kidney Disease Initiative (CKDI)

As a research consortium of physician scientists at 33 sites in the United States and Canada, along with patient advocacy groups NephCure Kidney International, the Alport Syndrome Foundation, and the Halpin Foundation, NEPTUNE strives to bring the latest advances in research to patients diagnosed with Focal Segmental Glomerulosclerosis (FSGS), Minimal Changes Disease (MCD), and Membranous Nephropathy (MN), with an overarching goal of utilizing precision medicine for rare diseases.

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.

NEPTUNE is a member of the Rare Disease Clinical Research Network (RDCRN). The RDCRN, a National Center for Advancing Translational Sciences (NCATS) initiative, includes 20 rare disease consortia which all strive to identify the causes, risks of progression, and potential new therapies for a broad spectrum of diseases.

^[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

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References

1. ^{^} https://certatherapeutics.com/ (certatherapeutics.com)
2. ^{^} https://www.prnewswire.com/news-releases/certa-therapeutics-investigational-drug-ft011-delivers-breakthrough-results-as-a-potential-novel-treatment-for-serious-inflammatory-and-fibrotic-diseases-301668533.html (www.prnewswire.com)