By Chris Wack
Lipella Pharmaceuticals shares were up 37% to $4.18 after the company said it saw positive topline results from its Phase 2a dose-ranging trial examining LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10 being developed to treat oral lichen planus.
The biotechnology company said LP-310 demonstrated a strong safety profile, with no product-related serious adverse events and no patient dropouts.
Oral lichen planus is a chronic inflammatory condition that affects the mucous membranes inside the mouth, on the tongue, cheeks, gums or palate.
The trial showed statistically significant improvements across multiple patient-reported and investigator-measured efficacy endpoints at weeks one, four and six, Lipella said.
The trial, which is active across seven U.S. sites, has progressed to the next higher dose cohort of 0.5 mg/10 mL.
Lipella continues to recruit for the trial, with plans to activate additional sites and complete the trial by mid-2025. The company is preparing for key milestones, including the submission of a Phase 2b clinical trial investigational new drug application in the second half of 2025 and a breakthrough therapy designation request to the Food and Drug Administration during the same period.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 11, 2025 12:56 ET (17:56 GMT)
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