FDA greenlights Lipella’s oral GVHD treatment trial
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PITTSBURGH – Lipella Pharmaceuticals Inc. (NASDAQ:LIPO), a clinical-stage biotechnology company, received approval from the U.S. Food and Drug Administration (FDA) to proceed with a clinical trial for its investigational drug LP-410, targeting the treatment of oral Graft-Versus-Host Disease (GVHD).
The FDA’s nod allows Lipella to initiate a multicenter, dose-ranging study to assess the safety, tolerability, and efficacy of LP-410 in patients suffering from symptomatic oral GVHD, with the trial set to begin in the second half of 2024.
Oral GVHD is a rare and serious condition that occurs when donor-derived immune cells attack the patient’s oral mucosa following Hematopoietic Cell transplantation (HCT), a procedure commonly used to treat various blood and bone marrow cancers. To date, there is no FDA-approved localized drug treatment for oral GVHD, representing a significant unmet medical need.
Lipella’s LP-410 is an oral rinse formulation of liposomal tacrolimus, a drug that aims to address the underlying mechanisms of oral GVHD potentially offering a safer and more effective treatment option by minimizing systemic toxicity. The company’s commitment to this therapeutic area is underscored by the FDA’s Orphan Drug Designation granted to tacrolimus for the treatment of GVHD on November 8, 2023.
Dr. Jonathan Kaufman, CEO of Lipella, expressed his enthusiasm about the trial’s approval, highlighting it as a pivotal milestone for the company in its quest to provide a solution for patients affected by this debilitating condition.
Dr. Michael Chancellor, Lipella’s Chief Medical Officer, also emphasized the significance of adding LP-410 to their pipeline, which now includes three IND-approved assets, two of which have received Orphan Disease Designation.
Lipella, which went public in December 2022, focuses on developing new drugs by reformulating existing generic drugs for new therapeutic applications, particularly targeting diseases with significant morbidity and mortality where no approved drug therapy exists.
The information provided in this article is based on a press release statement from Lipella Pharmaceuticals Inc.
