News & Events zu Lipella Pharmaceuticals Inc (LIPO)LIPOLipella Pharmaceuticals Inc

Lipella Pharmaceuticals Reveals Conclusive Findings from Phase 2a Trial of LP-10

Lipella Pharmaceuticals announced final results from its completed Phase 2a multicenter, dose-ranging study evaluating LP-10, a proprietary liposomal tacrolimus oral rinse, in patients with symptomatic oral lichen planus. The study met its primary safety endpoint and achieved statistically significant improvements across all efficacy measures at the 4-week timepoint. These results support LP-10's potential to become the first FDA-approved therapy for OLP, a chronic inflammatory condition that affects an estimated 6 million Americans, with no approved treatment options. Safety Profile: All 27 patients completed the full 4-week treatment course; No serious adverse events reported; Minimal systemic exposure: 76% of tacrolimus blood measurements were below detection limits; Well-tolerated, with only mild to moderate treatment-related adverse events; dry mouth being the most common, occurring in 18.5% of patients. Efficacy Outcomes: All three dose groups demonstrated statistically significant improvements at Week 4 on the secondary efficacy endpoints: Investigator Global Assessment showed clear reductions in ulceration and erythema scores; Pain and Sensitivity improved significantly, with patients reporting meaningful reductions on numerical rating scales; Patient symptoms, as measured by the OLP Symptom Severity Measure, demonstrated meaningful improvement in overall symptom burden; Sustained efficacy was observed, with all patients maintaining clinical benefit and no evidence of worsening through the 2-week follow-up period. The Phase 2a study was a multicenter, dose-ranging trial conducted at five leading U.S. clinical sites. Twenty-seven adults with biopsy-confirmed symptomatic OLP were sequentially enrolled into three dose cohorts. Patients used a 3-minute LP-10 oral rinse twice daily for 4 weeks, followed by a 2-week safety follow-up. The study population was representative of typical OLP patients: 81.5% were female, the median age was 62 years, and disease duration ranged from 1 to 28 years. All participants had previously failed standard therapies, including topical corticosteroids. Based on these results, Lipella is advancing LP-10 into late-stage development: Preparation of Phase 2b protocol incorporating FDA feedback; Scaling manufacturing capabilities to support larger clinical trials; Exploring strategic partnerships and collaborations

Lipella Pharmaceuticals announces U.S. patent issuance for diagnostic tech

Lipella Pharmaceuticals announced the issuance of U.S. Patent No. 12,326,492, titled "Systems and Methods of Detecting Interstitial Cystitis." The patent was issued by the United States Patent and Trademark Office on June 10, 2025, and provides protection through at least 2045, subject to potential extensions. The patent covers a method, using magnetic resonance imaging, to detect lesions in body cavities. "This method can potentially provide enhanced outcome assessments to our development programs; especially mucosal disorders, including our existing programs: LP-310 for oral lichen planus, LP-10 for hemorrhagic cystitis and LP-50 for bladder cancer." said Dr. Michael Chancellor, Chief Medical Officer.

Lipella Pharmaceuticals re-signs manufacturing collab with Cook MyoSite

Lipella Pharmaceuticals announced that it has re-signed its manufacturing collaboration agreement with Cook MyoSite to support Chemistry, Manufacturing and Control, CMC, documentation supporting our clinical products LP-10 and LP-310. Dr. Jonathan Kaufman, Chief Executive Officer and Co-Founder of Lipella, said, "We are pleased to renew our collaboration with Cook MyoSite, a trusted partner with a strong track record in high-quality manufacturing. This CMC collaboration is increasingly valuable to Lipella as our clinical pipeline matures toward commercializable assets."