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

TLY012 is a first-in-class death receptor 5 (DR5) targeting antifibrotic therapy. According to the Company, it selectively blocks normal fibroblast activation and induces apoptosis in myofibroblasts (MFB) in fibrotic tissues. 

“MFBs, or activated fibroblasts, are believed to be the critical originators of fibrosis, a condition that affects a variety of tissues and leads to excessive scar tissue accumulation, organ damage and poor medical outcomes,” said Viktor Roschke, PhD, CEO and head of R&D at Theraly.

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A phase 1/2a clinical trial is expected to begin in 2020. Preclinical models  investigating TLY012 have been promising, demonstrating reversal of established fibrosis.

Orphan Drug status is granted to treatments for rare diseases or disorders that affect fewer than 200,000 people in the US. 

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