Lipella Concludes Phase 2a Dosing for LP-310 in Oral Lichen Planus

Lipella Pharmaceuticals Inc has reported the conclusion of dosing for the initial group in its multi-center phase 2a clinical trial for LP-310, a liposomal-tacrolimus oral rinse intended for treating oral lichen planus (OLP). In the initial group, eight participants were given 0.25 mg of LP-310, showing encouraging early outcomes. 

There were no serious adverse events reported related to the product. Pharmacokinetic information showed that all patients had very low or unmeasurable whole blood tacrolimus levels, indicating that LP-310 could offer targeted treatment with limited impact on the entire body. Moreover, none of the patients experienced any major side effects while taking LP-310.

Janet Okonski, director of clinical operations at Lipella Pharmaceuticals, noted feedback from the study site, stating, “The tolerability observed in this initial cohort is a promising indicator. Oral lichen planus severely affects patient quality of life, and an effective, well-tolerated treatment is desperately needed. It’s encouraging to see this kind of response at an early stage.”

“We are proud of this milestone and are grateful to our investigators and study staff for their dedication and hard work,” said Dr. Michael Chancellor, chief medical officer of Lipella Pharmaceuticals. “Our commitment to developing a safe and effective therapy for oral lichen planus patients remains steadfast as we activate additional sites and begin enrolling the next dose cohort. The pace of our progress has been promising, and we are on track to deliver top-line data by year-end and complete the trial by mid-2025."