New York, March 06, 2024 - PRISM MediaWire - "Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) secures FDA Approval for Investigational New Drug (IND) Application, Advancing Clinical Testing of LP-410 for Oral Graft-Versus-Host Disease (GvHD) Treatment. Clinical Study Set to Commence in Second Half of 2024
Dr. Jonathan Kaufman, Lipella's CEO, expressed satisfaction with the FDA's approval of their IND application, stating, "We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024. This is an important milestone for Lipella as we pursue a potential treatment for this patient population."
Commenting on the development, Dr. Michael Chancellor, Lipella’s Chief Medical Officer, highlighted the potential of Lipella’s proprietary oral rinse formulation of liposomal tacrolimus to effectively treat oral GVHD while minimizing systemic toxicity.
Furthermore, Lipella is actively progressing liposomal tacrolimus for the treatment of hemorrhagic cystitis (LP-10) and oral lichen planus (LP-310). This addition to the company’s clinical assets represents a significant expansion of its pipeline, which now encompasses three IND-approved assets, two of which have received Orphan Disease Designation by the FDA.
Highlights
- LP-410 targets the underlying mechanisms of oral Graft-Versus-Host Disease (GvHD), potentially offering a safe and effective treatment option.
- Oral GvHD represents a severe and rare disease characterized by sensitivity and pain, significantly impacting a patient’s ability to eat, drink, and speak. Moreover, it heightens the risk of oral cavity infection, fibrosis, and potentially oral cancer. Currently, there are no FDA-approved local drug treatments for Oral GvHD.
- In November 2023, Lipella received FDA Orphan Drug Designation for tacrolimus in the treatment of GvHD. The FDA’s "Orphan Drug Designation" program extends orphan status to drugs and biologics designed for the treatment, prevention, or diagnosis of a rare disease or condition affecting fewer than 200,000 individuals in the United States.
About Lipella Pharmaceuticals
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, Lipella maintains a therapeutic focus on 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 www.lipella.com or LinkedIn.
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