US-based clinical-stage biotechnology company, Lipella, has announced US Food and Drug Administration approval for an Investigational New Drug (IND) for its oral lichen planus (OLP) treatment.

An upcoming multi-center, Phase IIa, dose-escalation clinical trial will assess the safety and efficacy of its drug, LP-310, in patients with symptomatic OLP. The T cell-mediated, autoimmune oral mucosal disease is liable to induce complications such as infections, scarring, stress and depression. At present most treatments for this condition are largely palliative.

The IND approval follows after the company formed a five-member Scientific Advisory Board in Oral Health in March of this year (2023) with the goal of developing LP-310 and developing the clinical strategy that will go into selecting prospective sites for the study.

As a result of the IND designation announced before markets opened on 20 October, the company’s stock rose by more than 47% once trading commenced. The company’s market cap is $12.4m.

Jonathan Kaufman, CEO of Lipella, said, “This FDA approval demonstrates our ability to significantly advance our value proposition by adding a phase-2, clinical-stage asset to our pipeline.”

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