At the close of the market, Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) stock stood at $0.8992, reflecting an increase of $0.4842 (116.67%). However, in after-hours trading, the stock price adjusted to $0.7950, a decrease of $0.10 (11.59%). Throughout the trading day, the stock ranged between $0.8100 and $1.5000, with a 52-week range of $0.3610 to $2.7100. The trading volume for the day was notably high at 193,926,230 shares, compared to an average volume of 46,406 shares. Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company dedicated to addressing serious diseases with significant unmet needs, has announced the enrollment of the first patients in its multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP).
About the Phase 2a Clinical Trial
This trial marks a significant milestone in the fight against Oral Lichen Planus, a chronic inflammatory condition that affects over 6 million Americans. Characterized by inflammation, pain, and ulceration of the mouth’s mucous membranes, OLP currently has no FDA-approved treatments. Lipella’s trial is a dose-ranging study of LP-310, a proprietary liposomal-tacrolimus oral rinse formulation derived from the company’s lead candidate LP-10 for hemorrhagic cystitis.
The trial has successfully enrolled its first patients across multiple research sites nationwide, from Philadelphia to San Francisco, and continues to screen additional subjects experiencing symptomatic OLP.
Executive Insights
Dr. Jonathan Kaufman, CEO of Lipella Pharmaceuticals, expressed his enthusiasm: “We are very pleased with the rapid pace of site activation, and the enrollment of our initial patients marks a pivotal milestone for both the company and the patient community suffering from this debilitating condition. This achievement reinforces our mission to redefine treatment paradigms for Oral Lichen Planus. With LP-310’s innovative approach to targeting disease mechanisms, we are excited about the potential to deliver a transformative therapy, alleviating symptoms and improving patient outcomes significantly.”
LP-310 is engineered to tackle the root causes of OLP, providing a promising alternative to current palliative treatments. It aims to deliver high local concentration in the oral cavity while minimizing systemic toxicity. The trial is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024.
Dr. Michael Chancellor, Chief Medical Officer of Lipella, added, “We have heard the urgency for new effective OLP therapies from patients, clinicians, and advocacy groups. OLP not only induces debilitating physical symptoms but also poses risks of serious complications. LP-310’s potential to mitigate these challenges represents a significant advancement in therapeutic options.”
Further Information
For more details on the clinical trial, please visit: Lipella Pharmaceuticals – LP-310 Oral Lichen Planus. Additionally, news about the trial is being shared on Facebook OLP support groups, with patients actively engaging and seeking more information.
About Oral Lichen Planus
Oral Lichen Planus (OLP) is a severe and debilitating condition characterized by oral mucosal lesions. It affects millions of individuals globally, presenting significant challenges in management and treatment. Current therapeutic options are limited, highlighting the critical need for innovative approaches like LP-310 to address this unmet medical need.
About Lipella Pharmaceuticals
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. The company targets diseases with significant unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit Lipella Pharmaceuticals or their LinkedIn page.
