Lipella Pharma Gets U.S. Patent for Liposomal Drug Delivery Platform

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology firm, has announced the receipt of a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for its innovative liposomal drug delivery platform. The patent, U.S. Patent No. 17/829,960, titled "Delivery of Agents Using Metastable Liposomes," pertains to the company's breakthrough methods of using liposome-based vehicles to deliver therapeutic agents. This advanced technology enhances the precision and targeting of drug delivery, thereby improving the safety and efficacy of treatments in diverse therapeutic fields, including oncology, cancer survivorship, and immunotherapy.

Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, expressed enthusiasm about the patent's allowance, highlighting its significance in bolstering the company's intellectual property portfolio. He emphasized the importance of the liposomal drug delivery system in administering therapeutics with greater safety and effectiveness by directly targeting disease sites, thus minimizing systemic side effects typically associated with these treatments. The patent covers Lipella’s method for using metastable liposomes to deliver various therapeutic agents, including the company’s leading assets, LP-10 and LP-310.

This newly allowed patent extends broad intellectual property protection, optimizing the delivery to epithelial tissues such as those in the mouth, bladder, colon, esophagus, vagina, and urethra. It not only secures market exclusivity for Lipella’s drug delivery platform but also strengthens the company's competitive edge, particularly for its two leading clinical assets currently in Phase 2 trials. Lipella’s growth prospects appear promising as the company advances its clinical pipeline, supported by additional patents for its formulations in the U.S., Australia, and Canada, effective until 2035.

Lipella’s leading clinical assets include LP-10 and LP-310. LP-10 is a liposomal formulation of tacrolimus intended for intravesical administration to treat hemorrhagic cystitis (HC), a severe condition characterized by bladder bleeding often resulting from radiation therapy or chemotherapy. LP-10 has demonstrated promising safety and efficacy results in a multicenter Phase 2a trial, significantly improving urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for the treatment of moderate to severe HC, underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial for LP-10 is poised to commence soon.

Meanwhile, LP-310 is an innovative oral rinse formulation of LP-10, designed to treat oral lichen planus (OLP), a chronic autoimmune disorder that affects the mucous membranes of the mouth. OLP can cause significant discomfort, scarring, and an increased risk of oral cancer. Despite affecting millions in the U.S., no approved pharmacotherapy exists for OLP. LP-310 offers a novel approach to treating this debilitating condition. A Phase 2a multicenter trial for LP-310 is currently underway, with top-line data anticipated by the end of the year and trial completion expected by mid-2025.

Lipella Pharmaceuticals focuses on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these formulations for new applications. The company prioritizes diseases with significant, unaddressed morbidity and mortality where no approved drug therapy exists. Since its initial public offering in December 2022, Lipella has continued to strive toward advancing its clinical pipeline and addressing unmet medical needs through innovative therapeutic solutions.