Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company, has renewed its manufacturing collaboration agreement with Cook MyoSite Inc. to support Chemistry, Manufacturing and Control (CMC) documentation for its clinical products LP-10 and LP-310. The partnership comes as the company advances its lead candidate LP-310, a non-steroidal oral rinse therapy for oral lichen planus (OLP), a condition with no approved treatments.
Clinical Progress Drives Manufacturing Partnership
The renewed collaboration supports late-stage development and scalable manufacturing for LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10. In April, Lipella reported positive topline results from the second cohort (0.50 mg) of its Phase 2a multicenter, dose-ranging trial evaluating LP-310 for the treatment of oral lichen planus.
"We are pleased to renew our collaboration with Cook MyoSite, a trusted partner with a strong track record in high-quality manufacturing," said Dr. Jonathan Kaufman, Chief Executive Officer and Co-Founder of Lipella. "This CMC collaboration is increasingly valuable to Lipella as our clinical pipeline matures toward commercializable assets."
Strategic Manufacturing Support
Cook MyoSite brings specialized expertise in regulated manufacturing and quality control to support Lipella's clinical development programs. The company operates several regulated clinical studies and provides custom services including contract manufacturing arrangements, quality control analytical testing, and assay development.
Ryan Pruchnic, Managing Vice President of Cook MyoSite and a member of Lipella's Board of Directors, emphasized the partnership's commitment to quality standards. "Our team is committed to ensuring high standards of safety, quality and execution, to support Lipella's clinical progress," Pruchnic stated.
Addressing Unmet Medical Need
Lipella focuses on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. The company targets diseases with significant unmet needs, where no approved drug therapies currently exist. LP-310 represents a potential breakthrough for patients with oral lichen planus, a condition that currently lacks approved treatment options.
The biotechnology company, which completed its initial public offering in 2022, continues to advance its clinical pipeline with support from strategic manufacturing partnerships designed to ensure scalable production capabilities as products move toward potential commercialization.
