Lipella Pharmaceuticals Inc. 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 millionSmall 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.

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. ICE-MRI is a proprietary liquid solution/suspension composed of two MRI contrast agents with unique magnetic properties that can be used to determine if bladder permeability defects are present. Lipella has completed preclinical validation of the agent and has commenced human clinical trials.

The novel contrast agent has a low cost of goods sold and a rapid diagnostic device development plan to meet urologic indications without current approved diagnostic imaging.