PRISM Q&A CORNER
Dr. Michael Chancellor , Co-Founder and Chief Medical Officer, Lipella PharmaceuticalsBringing Hope to Oral Lichen Planus Sufferers: Lipella’s Promising New Treatment Moves Forward
Oral Lichen Planus (OLP) is a chronic inflammatory disease that affects the mucous membranes inside the mouth, causing pain and discomfort, and significantly impacting the quality of life for those affected. This condition, which affects over 6 million Americans, often presents with lesions that can be painful and ulcerative.
The exact cause of OLP remains unknown, but it is believed to involve an immune response where the body’s white blood cells attack the mucosal lining of the mouth. Current therapeutic options are limited and the urgent need for effective treatments has driven ongoing research and clinical trials, including the promising efforts by Lipella Pharmaceuticals with their novel therapy, LP-310.
We sat down with Dr. Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals to learn more about the company’s innovative approach to bringing a new treatment to market.
Q:A:Our Phase 2a trial is a multicenter, dose-ranging study designed to evaluate the safety, tolerability, and efficacy of LP-310, a proprietary oral rinse formulation of our liposomal-tacrolimus product LP-10.
We have enrolled our first patients across multiple research sites nationwide, from Philadelphia to San Francisco and patient dosing is imminent. The trial involves approximately 24 subjects who will undergo a screening phase, a treatment phase using the LP-310 oral rinse twice a day for four weeks, and a follow-up phase. Our mission is to tackle the pressing need for an effective treatment for Oral Lichen Planus (OLP), a condition that currently has no FDA-approved therapies.
A:LP-310 is designed to address the underlying causes of OLP by delivering a higher local concentration of the drug directly to the affected areas in the oral cavity, while aiming to minimize systemic toxicity. This approach not only targets the disease mechanisms more effectively but also offers a significant improvement over current palliative treatments that primarily focus on symptom relief.
Our optimism is bolstered by the fact that LP-310 is a derisked asset. It is based on the same molecule as our lead candidate, LP-10, an intravesical liposomal formulation of tacrolimus intended for the treatment of moderate to severe hemorrhagic cystitis. LP-10 has already demonstrated preliminary safety and efficacy in a Phase 2a study, with a Phase 2b clinical trial expected to commence in the second half of 2024.
Q:A:We have heard a clear and urgent call for new effective therapies from patients, clinicians, and advocacy groups. Patients often describe debilitating physical symptoms that interfere with daily activities such as eating and speaking, and the psychological impact can be profound. Clinicians are frustrated by the lack of effective treatment options and the limitations of current therapies. Advocacy groups have been vocal about the need for innovative approaches that can offer real relief. This feedback reinforces our commitment to advancing LP-310 as a transformative therapy for OLP.
A:Following the completion of this Phase 2a trial, we will analyze the data to assess the safety and efficacy of LP-310. If the results are positive, we will move forward with larger, late-stage trials to further evaluate the treatment. Our goal is to provide a new, effective therapy for the millions of individuals suffering from OLP, ultimately leading to regulatory approval and making this treatment widely available.
A:Sure, for more information on the clinical trial, please visit: https://clinicaltrials.gov/study/NCT06233591. Or contact [email protected], news about the trial is being shared on Facebook OLP support groups, and patients are encouraged to reach out with questions.
Oral Lichen Planus (OLP) is a chronic inflammatory disease that affects the mucous membranes inside the mouth, causing pain and discomfort, and significantly impacting the quality of life for those affected. This condition, which affects over 6 million Americans, often presents with lesions that can be painful and ulcerative.
The exact cause of OLP remains unknown, but it is believed to involve an immune response where the body’s white blood cells attack the mucosal lining of the mouth. Current therapeutic options are limited and the urgent need for effective treatments has driven ongoing research and clinical trials, including the promising efforts by Lipella Pharmaceuticals with their novel therapy, LP-310.
We sat down with Dr. Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals to learn more about the company’s innovative approach to bringing a new treatment to market.
Our Phase 2a trial is a multicenter, dose-ranging study designed to evaluate the safety, tolerability, and efficacy of LP-310, a proprietary oral rinse formulation of our liposomal-tacrolimus product LP-10.
We have enrolled our first patients across multiple research sites nationwide, from Philadelphia to San Francisco and patient dosing is imminent. The trial involves approximately 24 subjects who will undergo a screening phase, a treatment phase using the LP-310 oral rinse twice a day for four weeks, and a follow-up phase. Our mission is to tackle the pressing need for an effective treatment for Oral Lichen Planus (OLP), a condition that currently has no FDA-approved therapies.
LP-310 is designed to address the underlying causes of OLP by delivering a higher local concentration of the drug directly to the affected areas in the oral cavity, while aiming to minimize systemic toxicity. This approach not only targets the disease mechanisms more effectively but also offers a significant improvement over current palliative treatments that primarily focus on symptom relief.
Our optimism is bolstered by the fact that LP-310 is a derisked asset. It is based on the same molecule as our lead candidate, LP-10, an intravesical liposomal formulation of tacrolimus intended for the treatment of moderate to severe hemorrhagic cystitis. LP-10 has already demonstrated preliminary safety and efficacy in a Phase 2a study, with a Phase 2b clinical trial expected to commence in the second half of 2024.
We have heard a clear and urgent call for new effective therapies from patients, clinicians, and advocacy groups. Patients often describe debilitating physical symptoms that interfere with daily activities such as eating and speaking, and the psychological impact can be profound. Clinicians are frustrated by the lack of effective treatment options and the limitations of current therapies. Advocacy groups have been vocal about the need for innovative approaches that can offer real relief. This feedback reinforces our commitment to advancing LP-310 as a transformative therapy for OLP.
Following the completion of this Phase 2a trial, we will analyze the data to assess the safety and efficacy of LP-310. If the results are positive, we will move forward with larger, late-stage trials to further evaluate the treatment. Our goal is to provide a new, effective therapy for the millions of individuals suffering from OLP, ultimately leading to regulatory approval and making this treatment widely available.
Sure, for more information on the clinical trial, please visit: https://clinicaltrials.gov/study/NCT06233591. Or contact [email protected], news about the trial is being shared on Facebook OLP support groups, and patients are encouraged to reach out with questions.
