Certa Therapeutics’ investigational drug FT011 offers breakthrough results as a potential new treatment for serious inflammatory and fibrotic diseases

  • Research presented today by University of Michigan Medical School Highlights Breakthrough Treatment Potential of FT011 from Human Expression Profiles in Chronic Kidney Disease Study Supported by Animal Model Data
  • Research has demonstrated that treatment with FT011 results in a remarkable reversal of the activation of genetic markers associated with fibrosis
  • Fibrosis is responsible for 45% of all deaths worldwide – FT011 is a new drug that may treat chronic fibrosis in several organs such as kidneys, skin, lungs, heart and eyes
  • Certa Therapeutics is a clinical-stage biotechnology company based in Melbourne, Australiadeveloping innovative therapies for the treatment of fibrotic diseases

ANN ARBOUR, Mich. , November 4, 2022 /PRNewswire/ — A new study presented today by the University of Michigan reveals breakthrough results for Certa Therapeutics’ FT011, a potential new treatment for severe inflammatory and fibrotic diseases.

Results of a chronic kidney disease (CKD) study presented at Kidney Week 2022, the annual scientific meeting of the American Society of Nephrology, concluded that FT011 was highly effective in reversing marker activation molecules associated with fibrosis[1].

CEO of Certa Therapeutics, Professor Darren Kellyone of australia leading life science entrepreneurs and a leading expert in the study of fibrosis, said the findings are a critical breakthrough in the development of treatments for fibrosis – an unmet clinical need responsible for 45% of all deaths worldwide. industrialized world.

“These findings indicate significant promise for FT011 as a potential new therapeutic treatment for the treatment of fibrotic diseases and support our plans to advance this investigational drug into later-stage clinical trials,” said Professor Kelly. “The precision and insights gained from this transformative and disruptive research could change the way we identify and treat patients with chronic kidney disease.”

Comparative transcriptomic analysis with human kidney data identified potential predictive clinical profiles and biomarkers of patients most likely to respond to FT011 treatment for advanced kidney disease, 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 has shown that treatment with FT011 for 12 weeks in this model significantly reduced the gene response associated with the fibrosis characteristic of the human disease. Therefore, the study indicates a likely positive response in human patients with chronic kidney disease.

The data was presented by Dr. Matthias Kretzler Research Team. Dr. Kretzler is a world renowned nephrologist, University of Michigan Faculty of Medicine Professor and Principal Investigator of the Network for the Study of Nephrotic Syndrome (NEPTUNE) – a leading research consortium of physician scientists at 26 sites in United States and Canada who develops innovative experimental strategies to improve the diagnosis, management and treatment of kidney disease.

NEPTUNE recruited a prospective, longitudinal and observational cohort of more than 650 renal failure patients with proteinuria and glomerular disease. NEPTUNE holds one of the largest clinical cohorts in the world that allows analysis of patients’ clinical, histological, genetic and molecular information, combined with patient long-term outcome profiles as part of the standard of care.

“Using this dataset, there is strong indication that treatment of patients with FT011 may mirror the positive impacts observed in the animal study by reversing the activation of molecular markers associated with fibrosis,” says Dr. Kretzler. “FT011 has demonstrated highly effective potential in the treatment of fibrotic disease. In my many decades of research, I have never seen such a significant result in our model regarding the potential of a drug to treat fibrosis in CRF.

Certa Therapeutics’ fibrosis research program has been in development for over 15 years. The company has identified and understood the genetic profile responsible for fibrosis, a significant scientific advance in the study of fibrotic diseases. FT011 is a new drug with the potential to treat chronic fibrosis in several organs such as kidneys, skin, lungs, heart and eyes.

“We have identified the fibrosis-linked biological receptor that 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.”

Key data from Certa Therapeutics’ Phase II trial in patients with scleroderma is expected to be published in early 2023.

AAbout 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 drug candidate platform and validated the role of a novel receptor that mediates signage 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 affecting the kidneys, lungs, eyes, skin and heart. The impact on morbidity and mortality from fibrotic diseases is substantial, ultimately causing 45% of all deaths worldwide.

Certa Therapeutics seeks to combine these innovative therapies with biomarkers and genetic analyzes to identify patients most likely to benefit from treatment. Significant breakthroughs are urgently needed in this area, addressing a market that is worth more than US$15 billion annually.

Groundbreaking research by Certa Therapeutics has identified a novel biological target in the mechanism of fibrosis 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 of this GPCR on multiple downstream pathways causing inflammation and fibrosis. FT011 is a new drug that inhibits this GPCR, offering potential to treat chronic fibrosis in multiple organs.


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

As a research consortium of medical scientists across 33 sites in United States and Canadaalong with patient advocacy groups NephCure Kidney International, the Alport Syndrome Foundation and the Halpin Foundation, NEPTUNE strives to bring the latest research advances to patients diagnosed with focal segmental glomerulosclerosis (FSGS), minimal modification disease (MCD) and membranous nephropathy (MN), with the primary objective of using precision medicine for rare diseases.

NEPTUNE aims to understand the causes of Nephrotic Syndrome (NS) and has gathered 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 move from observing the impact of NS on patients to finding new and effective ways to treat the disease. Most importantly, NEPTUNE will combine active disease triggers in a patient’s kidney with targeted clinical trials in pre-competitive partnerships with leading companies developing new treatments for NS.

NEPTUNE is a member of the Clinical Research Network on Rare Diseases (RDCRN). The RDCRN, an initiative of the National Center for Advancing Translational Sciences (NCATS), comprises 20 rare disease consortia that all strive to identify causes, risks of progression and potential new therapies for a wide range of rare diseases. 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

SOURCE Certa Therapeutic

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