Lipella Pharmaceuticals Inc. entered into a manufacturing collaboration agreement with Cook MyoSite Inc. to facilitate Chemistry, Manufacturing, and Control documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA. Lipella recently released positive topline results from its Phase 2a clinical trial evaluating LP-10 as a drug candidate for hemorrhagic cystitis, a rare and debilitating disease with no FDA approved treatments currently available.

The collaboration with Cook MyoSite, a company with 19 years of Good Manufacturing Practice ("GMP") manufacturing expertise, is expected to greatly accelerate Lipella's ability to bring new treatments to patients with unmet needs. Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, highlighted the importance of CMC documentation in the regulatory approval process, particularly for products developed via the FDA's 505(b)(2) pathway, such as LP-10. He emphasized that the collaboration with Cook MyoSite will play a crucial role in advancing the commercial approval of LP-10.

Ryan Pruchnic, Managing Vice President of Cook MyoSite, who is also a member of Lipella's board of directors, expressed Cook MyoSite's commitment to supporting Lipella's investigational products. With this collaboration, Lipella and Cook MyoSite are poised to make a greater impact in addressing the significant unmet need for effective treatments for hemorrhagic cystitis, and further advance LP-10 towards regulatory approval.