Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline
Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.
- Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.
- Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024.
- We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.
- Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.