Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has announced the issuance of U.S. Patent No. 12,138,345 by the U.S. Patent and Trademark Office (USPTO) for its proprietary liposomal drug delivery platform. The patent, officially issued on November 12, 2024, covers technological innovations that enable targeted delivery of therapeutic agents using liposome-based vehicles.
Key Innovations and Market Exclusivity
The patent, titled "Delivery of Agents Using Metastable Liposomes," protects Lipella's method of using metastable liposomes to deliver therapeutic agents. This provides broad intellectual property protection for the company’s drug delivery platform and extends market exclusivity for Lipella’s lead clinical assets, LP-10 and LP-310, both currently in Phase 2 clinical trials. With additional patents in the United States, Australia, and Canada, exclusivity is extended until 2035.
Clinical Assets: LP-10 and LP-310
LP-10 is a liposomal formulation of tacrolimus designed for intravesical administration to treat hemorrhagic cystitis (HC), a rare condition characterized by bladder bleeding. LP-10 has demonstrated promising safety and efficacy results in a multicenter Phase 2a trial, improving urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for moderate to severe HC, underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial is ready to begin.
LP-310 is an oral rinse formulation of LP-10 designed to treat oral lichen planus (OLP), a chronic autoimmune disease affecting the mouth's mucous membranes. LP-310 offers a new approach to treating OLP, which affects millions and currently lacks an approved pharmacotherapy. A Phase 2a multicenter trial is underway, with top-line data expected by year-end and trial completion by mid-2025.
Executive Commentary
"We believe our proprietary liposomal drug delivery platform holds significant potential to enhance efficacy and tolerability across various therapeutic areas, including oncology, cancer survivorship, and immunotherapy. This platform offers a safer, more effective way to administer therapeutics like tacrolimus, providing patients with targeted treatment options that minimize side effects," said Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals. "The official issuance of this strategically important patent marks a pivotal advancement for Lipella, strengthening our intellectual property portfolio and supporting our commitment to advancing treatments for critical conditions such as hemorrhagic cystitis and oral lichen planus."
