Lipella Pharmaceuticals has been granted “Orphan Drug Designation” from the FDAfor its drug candidate, LP-310, which has been designed for the treatment of oral Graft-versus-Host Disease. LP-310 is Lipella’s clinical stage pipeline asset intended to be indicated for inflammatory diseases of the oral cavity, including oral lichen planus and oral GvHD. LP-310 liposomal tacrolimus is a proprietary oral rinse formulation of Lipella’s lead drug candidate, LP-10. Lipella recently received FDA clearance for a Phase 2a clinical trial to evaluate LP-310’s safety and efficacy in patients with symptomatic oral lichen planus, which currently has no FDA approved treatment. Lipella’s LP-10 was previously granted Orphan Drug Designation by the FDA, making LP-310 the second of Lipella’s product candidates to receive this designation.
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