Nano Cap Lipella Pharmaceuticals Stock Jumps On Positive Trial Data In Patients With Sore Mouth Membranes

On Tuesday, Lipella Pharmaceuticals Inc. LIPO shared topline an analysis of its Phase 2a dose-ranging trial of LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10 being developed to treat oral lichen planus (OLP).

LP-310 demonstrated a strong safety profile, with no product-related serious adverse events (SAEs) or patient dropouts.

The trial showed statistically significant improvements across multiple patient-reported and investigator-measured efficacy endpoints at weeks 1, 4, and 6.

LP-310 is the only oral rinse topical treatment currently in development for OLP.

Affecting about 6 million Americans, OLP is a chronic inflammatory condition that targets mucous membranes in the mouth, which can cause pain and make eating, drinking, and even speaking uncomfortable.

Characterized by symptoms such as burning pain, white patches, swollen tissue and open sores, OLP has no FDA-approved therapies.

In the first cohort, eight participants received a twice-daily dose of 0.25 mg of LP-310. Follow-up visits occurred at one and four weeks and two weeks post-treatment.

The trial showed significant improvements across multiple efficacy endpoints while suggesting the safety and tolerability of LP-10 in adult patients with symptomatic OLP at the 0.25 mg/10 mL dose.

The trial has progressed to the next higher dose cohort of 0.5 mg/10 mL.

Pharmacokinetic analysis showed that tacrolimus blood levels were undetectable or minimal in all patients, underscoring LP-310’s potential to deliver localized benefits without systemic toxicity.

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 submitting a Phase 2b trial investigational new drug application and a Breakthrough Therapy designation request to the FDA in the second half of 2025.

The second cohort of the Phase 2a study is currently dosing, and topline data is expected in the first half of 2025.

Last week, the FDA granted approval for an Expanded Access Program for LP-310 for OLP. The program allows patients to access treatments outside of a clinical trial that has yet to be approved by the FDA.

Price Action: LIPO stock is up 38.80% at $4.24 at last check Tuesday.

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