Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.

Could long non-coding RNAs be the key to developing organ-specific antifibrotic drugs that only mediate their effects in disease-related contexts? That’s the intriguing hypothesis that Haya Therapeutics SA has set out to explore, and its lead program, in heart failure caused by non-obstructive hypertrophic cardiomyopathy, is now in IND-enabling studies. A first clinical trial is pencilled in for late 2024 or early 2025.

SFA Therapeutics Inc. has received FDA clearance of its IND application to investigate SFA-001N in patients with nonalcoholic steatohepatitis (NASH) with or without fibrosis.

Researchers from the University of Texas Medical Branch at Galveston have published preclinical data from a study that aimed to assess the role of gut microbiota-reactive Th17 cells in intestinal fibrosis, which is a significant complication of Crohn’s disease (CD).

Chimeric antigen receptor T-cell therapies and mRNA-based vaccines represent two of the most significant new modalities to gain regulatory approval in the past decade. Capstan Therapeutics Inc. has emerged from stealth with bold ambitions to combine these two approaches in mRNA-programmed cell therapies that will be generated in vivo from patients’ endogenous cells. It has so far secured $165 million in equity funding to pursue that vision.