GERMANTOWN, Md.–(BUSINESS WIRE)–Theraly Fibrosis, a preclinical-stage biotechnology company focused on development and commercialization of drugs for various fibrotic diseases today announced the company has been awarded a Small Business Innovation Research (SBIR) Phase II grant by the National Institutes of Health (NIH) in the amount of $3.9 million to support development of TLY012 for treatment of chronic pancreatitis.
“We are honored to receive this grant which builds upon the $2 million Phase I grant Theraly Fibrosis received in 2017,” said Viktor Roschke, Ph.D., Chief Scientific Officer at Theraly. “This Phase II grant helps support continued development of TLY012 which targets and blocks formation of activated fibroblasts and has the potential to be a first-in-class treatment for chronic pancreatitis as well as a range of other fibrotic diseases. Specifically, this grant will be used to support translation of TLY012 from the research phase to completion of an investigational new drug (IND) application.
Chronic pancreatitis is a progressive disorder that is characterized by pancreatic inflammation that causes fibrosis, which damages the pancreas and results in the loss of endocrine and exocrine function. Clinical manifestations of the disease include disabling abdominal pain and diabetes mellitus. Currently, there are no drugs available to significantly influence the natural course of the disease.
Research described in this new release is supported by the National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health under Award Number U44AA026111. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
TLY012 is a proprietary version of the recombinant human TRAIL protein with enhanced potency, stability and extended half-life in the bloodstream. TLY012 binds upregulated death receptor 5 (DR5) on myofibroblasts (MFBs) and shuts down fibrotic pathways. Treatment with TLY012 leads to reversal of established fibrosis in preclinical models of the disease in pancreas, skin and liver and potentially may become a revolutionary therapy for fibrotic diseases, including chronic pancreatitis, systemic sclerosis and liver fibrosis/cirrhosis. The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to TLY012 for the treatment of chronic pancreatitis.
About Theraly Fibrosis
Theraly is a preclinical-stage company whose mission is to develop innovative treatments for various forms of fibrotic disease including chronic pancreatitis, systemic sclerosis and NASH. The company’s lead candidate, TLY012, selectively targets myofibroblasts, cells believed to be the critical originators of fibrosis, a condition that affects a variety of tissues.