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Lipella Re-Signs Manufacturing Collaboration Agreement with Cook MyoSite

Supports late-stage development and scalable manufacturing for LP-310

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet need, has re-signed its manufacturing collaboration agreement with Cook MyoSite Inc. to support Chemistry, Manufacturing and Control (CMC) documentation supporting its clinical products LP-10 and LP-310.

In April, Lipella shared positive topline results from the second cohort (0.50 mg) of its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10, for the treatment of oral lichen planus (OLP).

Dr. Jonathan Kaufman, Chief Executive Officer and Co-Founder of Lipella, said, “We are pleased to renew our collaboration with Cook MyoSite, a trusted partner with a strong track record in high-quality manufacturing. This CMC collaboration is increasingly valuable to Lipella as our clinical pipeline matures toward commercializable assets.”

Ryan Pruchnic, Managing Vice President of Cook MyoSite and a member of Lipella’s Board of Directors, added, “Our team is committed to ensuring high standards of safety, quality and execution, to support Lipella’s clinical progress.”

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