Lipella Pharmaceuticals Doses First Patient in Human Study of Innovative Contrast Agent

Lipella Pharmaceuticals, a clinical-stage biotechnology company addressing serious diseases with significant unmet needs, today announces it has dosed the first patient in its human clinical study of a novel bladder MRI contrast agent.

Lipella’s contrast agent is composed of two MRI contrast agents and is expected to be useful for the diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) and potentially other bladder diseases characterized by bladder wall defects. Lipella believes the agent may also have utility in detecting bladder tumor progression to muscle-invasive bladder cancer.

The study is being funded by a $1.35 million Small Business Innovation Research (SBIR) Phase II grant awarded to Lipella by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2022. The two-year grant will support the clinical development of intravesical contrast-enhanced magnetic resonance imaging (ICE-MRI) technology, and is expected to accelerate clinical development of ICE-MRI, which could lead to important clinical results.

Dr. Michael Chancellor, Chief Medical Officer of Lipella expressed excitement about the milestone in developing a novel MRI contrast agent that can evaluate and detect leaky bladder.

“As a urologist, I know my clinical colleagues would highly welcome a new objective diagnostic modality that can accurately measure impaired bladder permeability and function,” said Dr. Chancellor.

Professor Pradeep Tyagi, a renowned scholar in the field of bladder pharmacology and imaging, emphasized that the agent can objectively phenotype IC/BPS that is bladder-centric, thereby identifying patients who would be most likely to benefit from clinical trials of newer therapies targeting bladder pathology and avoid the delay in getting appropriate medical care.