The five-member Board will initially focus on the development of LP-310, Lipella's product candidate for the treatment of symptomatic oral lichen planus
Lipella Pharmaceuticals, a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has announced the creation of a Scientific Advisory Board in oral health.
The five-member board will initially focus on the development of LP-310, Lipella's product candidate for the treatment of symptomatic oral lichen planus (OLP). LP-310 is a proprietary liposomal oral rinse formulation of liposomal tacrolimus.
The board will also provide guidance on the design of the company's phase 2a multicenter dose escalation study of LP-310 for IND submission and will assist Lipella with additional indications in oral liposomal drug delivery and treatment.
Dr Jonathan Kaufman, Chief Executive Officer of Lipella, said: "We are honoured to include this group of highly regarded experts in oral medicine to help us prepare a Phase 2a clinical trial for the treatment of OLP."
Members of the advisory board include:
Dr Michael Chancellor, M.D., Chief Medical Officer of Lipella, said: "The successful regulatory approval and initiation of the clinical trial of LP-310 will be a critical milestone in Lipella's development. This milestone takes us one step closer to bringing a first-in class treatment for oral lichen planus, a disease that affects over six million Americans and represents great unmet medical need."
Tacrolimus is an FDA-approved drug. Lipella is working to develop tacrolimus via the 505(b)(2) regulatory pathway for oral cavity application. Lipella owns intellectual property rights to the drug's formulation.