Lipella Pharmaceuticals Announces Positive Phase 2a Results for LP-310 in Oral Lichen Planus Treatment

On February 11, 2025, Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) shared insights from the successful Phase 2a study of its product candidate, LP-310, for treating oral lichen planus (OLP). The company disclosed that it intends to reveal the positive topline results during the BIO CEO & Investor Conference on the same day.

The recent approval from the U.S. Food and Drug Administration (FDA) for LP-310 to be used in an expanded access program has been a significant milestone for Lipella Pharmaceuticals. This program enables patients to access treatments that are still under clinical trial investigation and are not yet FDA-approved.

In support of these announcements, Lipella Pharmaceuticals also released a press release on February 11th, further emphasizing its commitment to advancing the treatment of OLP. The company’s Investor Presentation, scheduled during the BIO CEO & Investor Conference, will provide detailed insights into the Phase 2a results of LP-310 and shed light on the future prospects of the company’s product candidates to potential investors and analysts.

Forward-looking statements included in this Form 8-K filing caution investors that the actual results might deviate from projected outcomes. The company’s ability to comply with regulatory standards, maintain appropriate liquidity, and secure additional finances for ongoing operations are some of the potential risks highlighted.

Investors and stakeholders are advised that these forward-looking statements are based on current expectations and involve inherent uncertainties and risks that could impact future performance. Lipella Pharmaceuticals remains committed to updating stakeholders on any material developments as required by law.

The company’s solid performance in the Phase 2a study of LP-310 signifies a step forward in Lipella Pharmaceuticals’ commitment to developing innovative solutions for the treatment of oral diseases, including OLP.

This press release contains information from the official Form 8-K filing by Lipella Pharmaceuticals Inc. dated February 11, 2025, and includes relevant Exhibits 99.1, 99.2, and 99.3 for further insights into the recent developments.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Lipella Pharmaceuticals’s 8K filing here.

About Lipella Pharmaceuticals

Lipella Pharmaceuticals Inc, a biotechnology company, focuses on developing drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for various applications. The company develops LP-10, a formulation of tacrolimus that has completed Phase 2a clinical trial for patients with radiation-induced hemorrhagic cystitis; LP-310, a formulation of tacrolimus for the treatment of oral lichen planus; and LP-410, an oral liposomal formulation of tacrolimus for the treatment of oral graft-versus-host disease (GVHD).