Lipella Pharmaceuticals Announces Creation of Oral Health Scientific Advisory Board

Rhea-AI Summary

Lipella Pharmaceuticals (Nasdaq: LIPO) announced the formation of a five-member Scientific Advisory Board focused on advancing LP-310, a liposomal tacrolimus oral rinse for treating symptomatic oral lichen planus (OLP). The Board will guide the development of a Phase 2a clinical trial for LP-310, seeking IND submission. OLP affects over six million Americans, presenting a significant unmet medical need. Dr. Jonathan Kaufman, CEO of Lipella, expressed confidence in the expertise of the Board members, who bring extensive qualifications in oral medicine. Lipella aims to leverage the 505(b)(2) regulatory pathway for developing LP-310, holding the intellectual property rights for its formulation.

Positive

• Formation of a qualified Scientific Advisory Board boosts credibility for LP-310's development.
• Focus on a significant unmet medical need affecting over six million Americans.
• Utilizing the 505(b)(2) regulatory pathway for LP-310 enhances prospects for expedited approval.

Negative

• Dependence on the successful initiation and regulatory approval of LP-310's clinical trials represents a risk.
• No current FDA-approved treatments for OLP may indicate market challenges.

Five-member Board will initially focus on the development of LP-310

PITTSBURGH, March 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the creation of a Scientific Advisory Board in oral health.  

The five-member Board will initially focus on the development of LP-310, Lipella's product candidate for the treatment of symptomatic oral lichen planus (OLP). LP-310 is a proprietary liposomal oral rinse formulation of liposomal tacrolimus.

The Board will also provide guidance on the design of the company's phase 2a multicenter dose escalation study of LP-310 for IND submission and will assist Lipella with additional indications in oral liposomal drug delivery and treatment.

Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, said, "We are honored to include this group of highly regarded experts in oral medicine to help us prepare a Phase 2a clinical trial for the treatment of OLP."

Members of the advisory board include:

• Alessandro Villa, DDS, PhD, MPH will serve as the inaugural Chair of the Scientific Advisory Board. Dr. Villa is the Chief of Oral Medicine, Oral Oncology and Dentistry at Miami Cancer Institute and Professor, Herbert Wertheim College of Medicine, Miami, FL.
• Michael Brennan, DDS, MHS, Chairman, Department of Oral Medicine/Oral & Maxillofacial Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC; Professor, Department of Otolaryngology/Head & Neck Surgery, Wake Forest University School of Medicine, Winston-Salem, NC. 
• Kamal Al-Eryani, DDS, PhD, Associate Professor of Orofacial Science, Chief of Oral Medicine Services, UCSF School of Dentistry, San Francisco, CA.
• Vidya Sankar, DMD, MHS, Associate Professor and Division Director for Oral Medicine, Tufts University School of Dental Medicine, Boston, MA.
• Hervé Y. Sroussi, DMD, PhD, Associate Surgeon and Director for Research, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital and an Associate Professor in the Department of Oral Medicine, Infection and Immunity at the Harvard School of Dental Medicine, Boston, MA.

Dr. Michael Chancellor, M.D., Chief Medical Officer of Lipella, said, "The successful regulatory approval and initiation of the clinical trial of LP-310 will be a critical milestone in Lipella's development. This milestone takes us one step closer to bringing a first-in class treatment for oral lichen planus, a disease that affects over six million Americans and represents great unmet medical need." 

Tacrolimus is an FDA-approved drug. Lipella is working to develop tacrolimus via the 505(b)(2) regulatory pathway for oral cavity application. Lipella owns intellectual property rights to the drug's formulation.

About Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory condition that affects the mucous surfaces of the oral cavity.  OLP is common, affecting 1% of the population, yet no U.S. Food and Drug Administration (FDA) approved treatment exists.  OLP may appear as lesions in the mouth that may cause burning, pain and affect quality of life.  OLP requires regular monitoring given patients have increased risk of developing oral dysplasia and oral cancer.  OLP is a disease with great unmet need. 

ABOUT LP-310

LP-310 is a liposomal tacrolimus formulation as an oral rinse treatment of OLP.  Tacrolimus is already an FDA approved drug enabling Lipella to develop via the 505(b)(2) regulatory pathway tacrolimus for oral cavity application. Lipella owns intellectual property rights to the drug's formulation.

ABOUT LIPELLA PHARMACEUTICALS INC.

Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, the company maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella recently completed an initial public offering in December 2022. For more information, visit www.lipella.com or LinkedIn for updates.

View original content:https://www.prnewswire.com/news-releases/lipella-pharmaceuticals-announces-creation-of-oral-health-scientific-advisory-board-301758892.html

SOURCE Lipella Pharmaceuticals Inc.

FAQ

What is Lipella Pharmaceuticals' new initiative regarding LP-310?

Lipella has created a Scientific Advisory Board to focus on the development of LP-310, a treatment for symptomatic oral lichen planus.

Who are the members of the Scientific Advisory Board at Lipella?

The Board includes experts in oral medicine, such as Dr. Alessandro Villa, Dr. Michael Brennan, and Dr. Kamal Al-Eryani.

What is the primary focus of LP-310?

LP-310 is aimed at treating symptomatic oral lichen planus, a chronic inflammatory condition affecting the oral cavity.

How does the 505(b)(2) regulatory pathway impact LP-310's development?

This pathway allows Lipella to expedite the approval process for LP-310, leveraging the existing FDA-approved tacrolimus.

What is the significance of oral lichen planus and its market potential?

OLP affects a substantial portion of the U.S. population, representing a critical unmet medical need in oral health, potentially opening a large market for LP-310.