TARS - Tarsus Pharmaceuticals gets FDA greenlight for TP-05 Lyme disease trial

Tarsus Pharmaceuticals (TARS) announces that the U.S. FDA has accepted the company’s Investigational New Drug ((IND)) application for TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease.Tarsus will initiate a Phase 1 single ascending dose and multiple ascending dose study, which is expected to start in July, to evaluate the safety, tolerability, and pharmacokinetics ((PK)) of TP-05 in healthy volunteers.Lyme disease impacts more than 300K people in the U.S. each year and over 30M are at high or moderate risk for contracting the disease.Tarsus is currently conducting a pivotal trial evaluating the efficacy and safety of TP-03, a topical ophthalmic formulation of lotilaner, for the treatment of Demodex blepharitis, a common ocular condition caused by an infestation of Demodex mites.

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Tarsus Pharmaceuticals gets FDA greenlight for TP-05 Lyme disease trial