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Lipella Pharmaceuticals (LIPO) investor relations material
Lipella Pharmaceuticals Life Sciences Virtual Investor Forum 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Corporate strategy and technology
Proprietary multi-lamellar liposomal technology enables targeted drug delivery to mucosal tissues, minimizing systemic exposure and enhancing safety and efficacy.
Focus on serious conditions lacking adequate treatments, leveraging the 505(b)(2) regulatory pathway for efficient clinical development.
Asset pipeline includes two phase two assets, one IND-approved asset, and one preclinical asset, all using liposomal formulations.
Lead asset, LP-10 oral rinse (LP-310), targets oral lichen planus (OLP), a T-cell-mediated autoimmune disorder with no approved therapies.
Clinical trial results and safety
Phase two multi-center dose escalation study involved 27 adults with moderate to severe OLP, using LP-10 oral rinse twice daily for four weeks.
No serious adverse events or discontinuations; most adverse events were mild to moderate, with minimal systemic absorption of tacrolimus.
76% of subjects had undetectable blood levels of tacrolimus; no cases of hypertension, renal impairment, or allergic reactions.
Over 1,500 doses were well tolerated, with no intractable pain or significant side effects.
Efficacy and patient outcomes
Statistically significant improvements in clinician-assessed and patient-reported outcomes, including pain, sensitivity, and symptom severity, observed as early as week one and sustained through week six.
All participants reported some improvement, with most noting moderate to much improvement by week four.
Three patients who failed conventional steroid rinses improved and received expanded use access from the FDA.
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