Clinical Trials at Lipella Pharmaceuticals
Lipella has successfully completed a Phase 2a, dose-escalation clinical trial evaluating LP-10 (liposomal tacrolimus) for the treatment of hemorrhagic cystitis (HC). Results were published in the peer-reviewed journal, International Urology and Nephrology. Lipella has received FDA Orphan Designation for this product. The company expects to initiate its Phase 2b trial in LP-10 in H1 2024.
If you are a cancer survivor with a history of pelvic radiation therapy, please consider joining the Radiation Cystitis Patient Registry.
Additional resources are needed to advance RC understanding – including the development of new and larger RC patient registries. The RC Foundation highlights the Radiation Cystitis Patient Registry, which aggregates data on the health status of individuals with RC.
The goal of the Radiation Cystitis Patient Registry is to create a resource to help doctors better recognize severe complications that arise long after pelvic radiation treatments. Researchers also use the Patient Registry to study RC treatments and outcomes and to design RC clinical trials.
Lipella was granted FDA approval to evaluate LP-310 in patients with oral lichen planus (OLP). This phase 2A multi-center, dose-escalation clinical trial will assess the safety and efficacy of LP-310 in patients with symptomatic OLP. Patient recruitment is underway, and clinical testing of LP-310 is expected to commence in 2H 2024.
LP-410 is an oral rinse formulation intended for the treatment of oral Graft-versus-Host Disease (GvHD), a rare and serious disease. GvHD is a major cause of morbidity and mortality with chronic GvHD being the leading cause of nonmalignant fatality post hematopoietic cell transplantation (HCT).
LP-50 is an intravesical formulation for local, intravesical PD-1 (i.e. checkpoint) inhibition, intended for the treatment of non muscle invasive bladder cancer (NMIBC). Intravesical immunotherapy presents a promising avenue for bladder cancer treatment, offering the potential for increasing efficacy while minimizing systemic toxicity.
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