Lipella Pharmaceuticals has entered into a manufacturing collaboration agreement with Cook MyoSite to facilitate Chemistry, Manufacturing, and Control (CMC) 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 Michael Chancellor, Chief Medical Officer, Lipella, expressed his enthusiasm about the partnership, stating, "Cook MyoSite's reputation for quality and safety standards, along with their extensive experience in GMP manufacturing, will be invaluable as we develop our IND application for LP-10. We are confident that this collaboration will expedite our efforts to produce clinical supplies and research products for LP-10, ultimately benefiting patients."

Dr Jonathan Kaufman, CEO, 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, Cook MyoSite, who is also a member of Lipella's board of directors, expressed Cook MyoSite's commitment to supporting Lipella's investigational products.

"LP-10 is an outstanding drug candidate with immense potential to treat patients in need. We are excited to share our knowledge and expertise in GMP manufacturing and contribute to the advancement of this promising therapeutic," said Pruchnic.

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.