oral tacrolimus liposomal (LP-310) / Lipella Pharma - LARVOL DELTA

Lipella Pharmaceuticals Re-signs Manufacturing Collaboration Agreement with Cook MyoSite to Support LP-310 Clinical Development (GlobeNewswire) - "Lipella Pharmaceuticals Inc...today announced that it has re-signed its manufacturing collaboration agreement with Cook MyoSite, Inc...to support Chemistry, Manufacturing and Control (CMC) documentation supporting our clinical products LP-10 and LP-310."

Commercial • Lichen Planus

Lipella Pharmaceuticals Completes Enrollment in Phase 2a Trial of LP-310 for Oral Lichen Planus (GlobeNewswire) - "Lipella Pharmaceuticals Inc...today announced the completion of enrollment in its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse for the treatment of oral lichen planus (OLP). The Phase 2a trial has now fully enrolled participants across all three dose cohorts (0.25 mg, 0.50 mg and 1.0 mg of tacrolimus) at seven U.S. study sites. Topline results from the final cohort (1.0 mg) remain on track for the second quarter of 2025 and will represent the most comprehensive clinical dataset to date for LP-310....Submit an Investigational New Drug (IND) application for a Phase 2b trial in late 2025."

Enrollment closed • IND • New P2b trial • P2a data • Lichen Planus

Lipella Pharmaceuticals Reports Positive Topline Phase 2a Results for LP-310 in the Treatment of Oral Lichen Planus (GlobeNewswire) - P2a | N=NA | "Lipella Pharmaceuticals Inc...shared topline analysis of its Phase 2a multicenter dose-ranging trial examining LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10 being developed to treat oral lichen planus ('OLP')....Investigator Global Assessment (IGA): Improved from 3.50 ± 0.19 at baseline to 2.75 ± 0.31 at week 1 (p=0.031), 1.75 ± 0.45 at week 4 (p=0.008), and 2.80 ± 0.37 at week 6 (p=0.125). Reticulation, Erythema, and Ulceration (REU) Score: Reduced from 27.75 ± 2.71 at baseline to 17.56 ± 2.51 at week 1 (p=0.004), 12.69 ± 3.06 at week 4 (p=0.004), and 19.60 ± 4.31 at week 6 (p=0.031). Oral Lichen Planus Symptom Severity Measure (OLPSSM): Decreased from 15.38 ± 2.20 at baseline to 10.13 ± 2.34 at week 1 (p=0.035), 5.00 ± 2.28 at week 4 (p=0.004), and 8.60 ± 4.06 at week 6 (p=0.031)."

P2a data • Lichen Planus

Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus (GlobeNewswire) - "Lipella Pharmaceuticals Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Expanded Access Program (EAP) for LP-310, an oral rinse formulation designed to treat oral lichen planus (OLP)."

FDA event • Lichen Planus

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished (GlobeNewswire) - "The Company is poised to submit a Phase 2a IND for this indication in the first quarter of 2024....Lipella has been granted orphan drug designation by the FDA for LP-310 in the treatment of GVHD."

IND • Graft versus Host Disease

FDA Grants Orphan Designation for Lipella’s LP-310 Drug Candidate for Oral Graft-versus-Host Disease (PRNewswire) - "Lipella Pharmaceuticals Inc....announced today that it has been granted 'Orphan Drug Designation' from the U.S. Food and Drug Administration (FDA) for its drug candidate, LP-310, which has been designed for the treatment of oral Graft-versus-Host Disease (GvHD)."

Orphan drug • Graft versus Host Disease • Immunology