Lipella Pharmaceuticals Enters Manufacturing Collaboration with Cook MyoSite

Clinical stage biotechnology company, Lipella Pharmaceuticals (Nasdaq: LIPO) has entered a manufacturing collaboration with Cook MyoSite for its lead drug candidate, LP-10.

In March 2023, the company successfully completed a Phase 2a clinical trial evaluating LP-10 as a potential therapeutic for hemorrhagic cystitis, a rare and debilitating disease with no approved treatment.

Highlights

Lipella’s collaboration with Cook MyoSite will facilitate Chemistry, Manufacturing, and Control (“CMC”) documentation for LP-10 (liposomal tacrolimus). Cook MyoSite has 19 years of GMP manufacturing expertise.

Lipella states that the collaboration will expedite its efforts to produce clinical supplies and research products for LP-10, and will play a crucial role in advancing the commercial approval of LP-10.

The company has entered the agreement in anticipation of its forthcoming Investigational New Drug (IND) application.

LP-10 has been granted Orphan Drug Designation by the FDA.

About Lipella Pharmaceuticals

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. For more information, please visit www.lipella.com or LinkedIn.

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Lipella Pharmaceuticals Enters Manufacturing Collaboration with Cook MyoSite

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