Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. 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.
