Mediar Therapeutics Inc. emerged from stealth, unveiling $105 million in investment and bold ambitions to develop new ways of tackling fibrosis. Cambridge, Mass.-based Mediar is challenging what CEO Rahul Ballal called “the fundamental dogma” of fibrosis therapy: “You have to address fibrosis at its initiation, when inflammation is rampant.” Mediar, in contrast, is focused on developing therapies that either disrupt or reverse the fibrotic process, particularly when it progresses from a moderate to a severe state.

While it is known that differentiated myofibroblasts produce excessive collagens, which accumulate in tissues and cause hardening, the mechanisms involved in these processes are largely unknown. In a recent study, Kyushu University scientists aimed to assess the molecular mechanisms by which matrix stiffness increases fibrosis-related gene expression in myofibroblasts.

Scientists at the University of Sydney have discovered a protein in the lung that blocks SARS-CoV-2 infection and forms a natural protective barrier in the human body. Leucine-rich repeat-containing protein 15 (LRRC15) is an inbuilt receptor that binds the SARS-CoV-2 virus without passing on the infection. The discovery opens a new area of immunology research around LRRC15 and suggests a pathway to develop new drugs to prevent viral infection from coronaviruses like COVID-19, but also to deal with fibrosis in the lungs.

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.

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.