• Lipella awarded $1.35m grant in 2022 for development of intravesical contrast-enhanced magnetic resonance imaging (ICE-MRI) technology.

PITTSBURGH, April 5, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, 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.

About ICE-MRI, a Duel-Component MRI Contrast Agent

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.

ABOUT LIPELLA PHARMACEUTICALS INC.

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 trading on Nasdaq under the ticker LIPO. For more information, please visit www.lipella.com or LinkedIn.

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