Vivoryon Therapeutics N.V. has strengthened its intellectual property position with a new U.S. patent covering varoglutamstat, the company's lead drug candidate for kidney disease treatment. The United States Patent and Trademark Office granted the composition of matter patent (US 12,312,335) through an accelerated examination process, providing market exclusivity through 2044 with potential extension to 2049 under the Hatch-Waxman Act.
Patent Scope and Strategic Importance
The newly granted patent specifically covers the only polymorph of the salt form used in varoglutamstat's drug product formulation. As a unique QPCT/L inhibitor, varoglutamstat represents Vivoryon's primary therapeutic focus in kidney disease development.
"This successful patent application demonstrates our strong commitment to protecting the innovation of our lead asset varoglutamstat and is an important milestone for Vivoryon," said Frank Weber, MD, CEO of Vivoryon. "The fact that it has been granted several months ahead of the anticipated timing is a testament to the outstanding work of our team."
Expanding Kidney Disease Portfolio
Beyond the core composition patent, Vivoryon has filed multiple additional patent applications targeting kidney disease applications. These submissions cover varoglutamstat and related structures for medical use and dosing regimens, both as monotherapy and in combination with SGLT-2 inhibitors, which represent the current standard of care.
The combination therapy patents stem from preclinical research demonstrating synergistic effects when varoglutamstat is combined with SGLT-2 inhibitors. The data revealed enhanced therapeutic benefits with both once and twice daily treatment regimens, supporting the rationale for combination approaches in kidney disease management.
Comprehensive IP Strategy
Vivoryon's patent portfolio for QPCT/L inhibition now encompasses over 20 patent families and more than 400 patent applications and issued patents across major global markets. The portfolio spans composition of matter, medical use, indications, and dosing regimens, with composition of matter patents representing the majority of holdings.
The company's IP strategy extends beyond kidney diseases to cover QPCT/L inhibitors across multiple therapeutic areas including inflammatory diseases, oncology, genetic disorders, and fibrotic diseases. Recent patent applications reflect Vivoryon's strategic focus on kidney disease applications, with additional protection covering both the free base and all salt forms of varoglutamstat currently under examination.
Technology Platform and Development Focus
Vivoryon operates as a clinical-stage biotechnology company specializing in small molecule medicines that modulate the activity and stability of pathologically altered proteins. The company leverages expertise in post-translational modifications to develop orally available inhibitors across various therapeutic areas.
The company's pipeline includes small molecule inhibitors for Alzheimer's disease, inflammatory and fibrotic disorders including kidney diseases, and cancer applications. Weber emphasized that the extended patent runway will support efforts to maximize varoglutamstat's full therapeutic potential in kidney disease development.
The patent grant represents a significant milestone in Vivoryon's strategy to build comprehensive intellectual property protection around its lead therapeutic programs, particularly as the company advances varoglutamstat through clinical development for kidney disease applications.
