Certa Therapeutics' FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

Certa Therapeutics Australia

Accessed October 9, 2022.https://certatherapeutics.com/ground-breaking-results-in-phase-2-scleroderma-study-by-certa-therapeutics-demonstrates-improvement-in-more-than-60-of-patients/ A formal sample size calculation for efficacy endpoints was not conducted for this study.D Khanna, et al., Arthritis Rheumatol. 2016; 68(2): 299–311. doi:10.1002/art.39501S Eddy, et al., "Identification of Non-Invasive Surrogates as Predictors of Response to FT011 in Kidney Disease" ASN Kidney Week 2022, abstract 3767783

About the Phase 2 study
Certa's Phase II trial was a randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects and safety of oral FT011 doses in participants with diffuse systemic sclerosis (SSc).

ClinicalTrials.gov Identifier: NCT04647890

About Systemic Sclerosis (Scleroderma)
Scleroderma is an extremely debilitating, potentially life-threatening autoimmune condition characterised by inflammation and fibrosis of the skin and other organs (commonly the lungs, kidneys, and heart). This condition results in high morbidity with substantial detriment on quality of life, with patients commonly experiencing loss of mobility and function, pain, fatigue, often accompanied with a significant impact to their mental health. Scleroderma has the highest mortality among rheumatic diseases associated with a 2.5-fold higher risk of mortality than the general population.

About Certa Therapeutics & FT011
Certa Therapeutics is a biotechnology company focused on improving lives by treating patients with debilitating diseases via novel targeted therapies. Since its inception in 2018, Certa has secured over $28m from Australian investors Brandon Biocatalyst and Uniseed.

FT011 is a novel, first-in-class oral therapy for the treatment of chronic fibrosis in multiple organs advancing through clinical development for scleroderma (systemic sclerosis). It targets a previously important but undrugged membrane GPCR receptor with an extensive body of data demonstrating promising efficacy in multiple models of fibrotic disease. Transcriptomic research has demonstrated that treatment with FT011 results in reversal in the activation of genetic markers associated with fibrosis, providing potential for a precision therapy.5

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% 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.

FT011 is an investigational product which has not received marketing authorisation or approval by any regulatory agency, including the US Food and Drug Administration, the European Medicines Agency, or the Australian Therapeutic Goods Agency. The investigational drug products being developed by Certa Therapeutics are undergoing clinical studies to evaluate the safety and effectiveness in humans.

https://certatherapeutics.com/

Follow us on LinkedIn https://www.linkedin.com/company/certa-therapeutics/ 

View original content:https://www.prnewswire.co.uk/news-releases/certa-therapeutics-ft011-granted-us-fda-orphan-drug-designation-for-the-treatment-of-systemic-sclerosis-301961921.html

@ prnewswire.co.uk