Lipella Pharmaceuticals Shares Promising Topline Phase 2a Data for LP-310

February 11, 2025

DENVER, Colo., Feb 11, 2025 (247marketnews.com)- Lipella Pharmaceuticals (NASDAQ:LIPO) released positive topline data from its Phase 2a multicenter dose-ranging trial of LP-310, a liposomal-tacrolimus oral rinse formulation being developed to treat oral lichen planus (OLP).

The trial demonstrated statistically significant improvements in various patient-reported and investigator-measured endpoints:

Investigator Global Assessment (IGA) showed improvement from baseline scores, indicating clinical improvement in the severity of the condition.

The Reticulation, Erythema, and Ulceration (REU) score, a measure of inflammation and ulceration in the mouth, decreased significantly, which suggests that LP-310 is effective in reducing OLP-related symptoms.

The Oral Lichen Planus Symptom Severity Measure (OLPSSM) improved, reflecting a decrease in symptom severity over time.

The Pain Numerical Rating Scale (NRS), indicating the level of discomfort from OLP, showed substantial improvement, with a notable reduction in pain at weeks 1, 4, and 6.

The Global Response Assessment (GRA) also showed improvement, suggesting that patients experienced meaningful clinical benefits from LP-310.

Dr. Michael Chancellor, Lipella’s Co-Founder and CMO, commented, “The statistically significant reductions in pain, ulceration, and inflammation observed in this trial provide strong grounds for the scientific validation of LP-310’s efficacy. These results, combined with the treatment’s favorable safety profile, highlight the potential of LP-310 to deliver a highly targeted and tolerable therapy for OLP. We are deeply grateful to the patients and investigators for their contributions to this critical study and inspired by the marked improvements we’ve seen in patients’ lives. We look forward to advancing the trial to the next dose cohort and expanding recruitment across seven active U.S. sites as we continue to build on these promising findings.”

These findings strongly suggest that LP-310 can effectively treat OLP symptoms, such as pain, swelling, and ulcers, providing relief to patients suffering from this chronic, debilitating condition.

LP-310 was well tolerated, with no serious adverse events (SAEs) related to the treatment and no patient dropouts. This is particularly important because OLP treatments are often plagued by side effects, and demonstrating a clean safety profile could make LP-310 an attractive option for patients seeking relief from the condition.

Pharmacokinetic analysis showed that tacrolimus levels in the blood were undetectable or minimal, indicating that LP-310 provides localized benefits with little to no systemic exposure or toxicity. This is crucial as it suggests that LP-310 may deliver therapeutic effects directly to the affected areas in the mouth without causing systemic side effects commonly associated with oral or systemic therapies.

Jonathan Kaufman, Lipella’s Co-Founder and CEO, stated, “OLP represents a significant unmet need, and these remarkable results are highly encouraging, underscoring the meaningful value LP-310 can bring to both patients and the broader healthcare system. With a chronic condition like OLP, delivering a targeted, effective treatment that overcomes the challenges of current options is vital. We are thrilled to advance its development and unlock its full potential.”

Oral lichen planus (OLP) is a chronic inflammatory condition affecting about 6 million Americans, with symptoms such as pain, swelling, white patches, and ulcers in the mouth. There are currently no FDA-approved therapies for OLP, making it a condition with a significant unmet medical need.

LP-310’s oral rinse formulation is currently the only topical treatment in development for OLP, potentially giving Lipella Pharmaceuticals a first-mover advantage in this market. The strong efficacy and safety data could position LP-310 as a potential breakthrough treatment for OLP, providing much-needed relief to patients who currently rely on symptom management strategies, such as steroids or other off-label treatments.

Lipella continues to recruit participants for the Phase 2a trial and plans to activate additional sites, with completion expected by mid-2025. Lipella also plans to submit a Breakthrough Therapy designation request to the FDA, which could help expedite the development and approval process for LP-310, given the unmet need for effective OLP treatments.

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