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.
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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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