The Food and Drug Administration (FDA) has granted Orphan Drug designation to TLY012 (Theraly Fibrosis) for the treatment of systemic sclerosis.

Systemic sclerosis is a rare, chronic autoimmune rheumatic disorder characterized by diffuse fibrosis and vascular abnormalities in the skin, joints, and internal organs. TLY012, a PEGylated recombinant human TRAIL (TNF-related apoptosis-inducing ligand) protein, binds upregulated death receptor 5 (DR5) on myofibroblasts (MFBs) and selectively blocks activation of MFBs in fibrotic regions. Results from preclinical studies have shown TYL012 to reverse existing fibrosis in various animal models with liver, skin, and pancreatic fibrosis.

“Targeting the TRAIL pathway with TLY012 may represent a promising anti-fibrotic strategy to arrest scleroderma in humans,” said Viktor Roschke, PhD, CSO and head of R&D at Theraly. “Because TLY012 targets and blocks the formation of MFBs regardless of tissue location, it has the potential to not only be a first-in-class treatment for systemic scleroderma, but also for other fibrotic diseases.”

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Additionally, the Company is investigating TLY012 for the treatment of nonalcoholic steatohepatitis (NASH) liver fibrosis and chronic pancreatitis.

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