(Health Korea News / Lee Chang-yong) D&D Pharmatech announced on the 19th that it has finally received registration of a new substance and use patent for its fibrosis disease treatment pipeline TLY012 in Australia.
According to the company, this new patent was filed through Neuraly, a 100% US subsidiary of D&D Pharmatech. TLY012 is a next-generation candidate that can significantly reduce potential immunogenicity compared to the company’s existing patented substances, thereby expanding the scope of clinical applications. This is the second major country patent registration following the US patent obtained in September 2023.
TLY012 is a recombinant protein drug of the tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) series. It selectively acts on the DR5 (Death Receptor-5) receptor of myofibroblasts, the fundamental cause of fibrosis. As a result, it has high anti-fibrosis activity while having few side effects by rapidly killing only myofibroblasts in fibrotic tissues without affecting normal cells.
The company said, “We have confirmed excellent preclinical efficacy in animal models of cirrhosis, systemic sclerosis, and chronic pancreatitis, in which fibrotic tissues are restored to normal levels.” The results of the study have been published in leading international journals such as Hepatology (Impact factor: 26.8) and Nature Communications (Impact factor: 14.7).
This drug received orphan drug designation from the US FDA in 2019 and 2020 for chronic pancreatitis and systemic sclerosis, respectively. If designated as an orphan drug, it can receive various support and benefits during the future development and commercialization process.
D&D Pharmatech CEO Lee Seul-ki said, “TLY012 is a next-generation bio product that we have high expectations for, following DD01, a GLP-1 series drug that is currently in phase 2 clinical trials targeting MASH (metabolic steatohepatitis) patients.” He added, “In particular, in the current situation where there is no pipeline targeting end-stage fibrosis that can cover up to cirrhosis, D&D has a differentiated portfolio that can cover the entire disease stage from MASH to cirrhosis through the development of DD01 and TLY012.”
The company emphasized, “The expiration date for this new material/use patent is after 2040.”
D&D Pharmatech has applied for a total of 80 patents related to MASH and fibrotic diseases in major countries around the world. The number of registered patents continues to increase every year.
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