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FDA Grants Orphan Drug Designation for Chronic Pancreatitis Candidate
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The FDA granted orphan drug designation to Theraly Fibrosis for the company’s TLY012, a recombinant human TRAIL protein under investigation for the treatment of chronic pancreatitis, according to a press release.
“[Myofibroblasts (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,” Viktor Roschke, PhD, CEO and head of research and design at Theraly, said in the release. “Because TLY012 targets and blocks the formation of MFBs regardless of tissue location, it has the potential to be a first-in-class treatment for a range of fibrotic diseases in addition to chronic pancreatitis.”
Early data showed that treatment with TLY012 led to reversal of established fibrosis in the pancreas, skin and liver.
Theraly plans to initiate a phase 1/2a clinical trial in 2020.
Reference: www.ddpharmatech.com