D&D Pharmatech's fibro disease drug candidate wins patent in Australia

D&D Pharmatech said Friday that it has completed registering new material and application patent in Australia for TLY012, a drug candidate in development for treating fibrotic diseases, such as liver cirrhosis, systemic sclerosis, and chronic pancreatitis.

The new patent, filed through Neuraly, the company's wholly-owned U.S. subsidiary, marks the second patent registry in major countries for TLY012, a next-generation candidate with significantly reduced potential immunogenicity compared to the company's existing patented compounds, which could lead to broader clinical applications, according to D&D Pharmatech.

The company won a similar patent in the U.S. in September last year

TLY012 is a recombinant protein medicine in the TNF-related apoptosis-inducing ligand (TRAIL) family that selectively acts on the death receptor-5 (DR5) receptor on myofibroblasts, the underlying cause of fibrosis.

So, it rapidly kills only myofibroblasts in fibrotic tissues without affecting normal cells, resulting in high anti-fibrotic activity with fewer side effects.

In animal models of liver cirrhosis, systemic neuropathy, and chronic pancreatitis, D&D Pharmatech has demonstrated excellent preclinical efficacy in restoring fibrotic tissue to normal levels, and the results of these studies have been published in foreign journals, including Hepatology and Nature Communications.

In 2019 and 2020, the company received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for chronic pancreatitis and systemic sclerosis, which provides important support and benefits for future development and commercialization.

“TLY012 is a highly anticipated next-generation biologic product that follows our GLP-1 lead DD01, which is currently in phase 2 clinical development in patients with MASH (metabolic-associated steatohepatitis),” D&D Pharmatech CEO Lee Seul-ki said.

Lee continued, “With the development of DD01 and TLY012, D&D has a differentiated portfolio that can cover the entire spectrum from MASH to cirrhosis, especially in the absence of a pipeline of end-stage fibrosis targets that can extend to the cirrhosis stage.”

A company official also said, “The new substance/use patents expire in 2040 and beyond, allowing D$D Pharmatech to maintain its proprietary technology for a longer period and strengthening its position in the global market through continued R&D and commercialization.”