Tarsus Achieves Positive Topline Results in Lyme Disease Trial

Tarsus Pharmaceuticals, Inc. (Nasdaq: TARS) has announced positive topline results from a Phase 2a trial evaluating TP-05 (lotilaner), a novel, investigational oral therapeutic for the prevention of Lyme disease. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission.

Tarsus’ trial is a randomized, double-blind, placebo-controlled trial evaluating the ability of TP-05 to kill ticks attached to subjects with a single treatment of TP-05 compared to placebo. High and low doses of TP-05 demonstrated a statistically significant benefit in killing ticks compared to placebo.

“Lyme disease remains a growing public health concern associated with long-term consequences for millions of patients and an estimated $1 billion dollar price tag for the U.S. healthcare system,” said Bobby Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “We are highly encouraged by these early proof-of-concept data and the opportunity to bring forward a novel, on-demand, oral treatment that addresses the root cause of disease – the ticks that transmit the bacteria that cause Lyme disease.” 


TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels.

Lyme disease is the most common vector-borne disease in the United States, transmitted by tick bites and resulting in debilitating symptoms including inflammation, nerve, joint and muscle pain and swelling, numbness, shortness of breath, neurological complications such as facial palsy, vision issues and meningitis, as well as cardiac complications.

In most cases, ticks must be attached for 36-48 hours or more before Lyme disease can be transmitted, so killing ticks within 24 hours of attachment can greatly increase the probability of disease prevention.

Currently, there are no FDA-approved pharmacological prophylactic options for Lyme disease. 

About Tarsus Pharmaceuticals, Inc.

Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology and infectious disease prevention. XDEMVY® (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-03 as an investigational therapy for the treatment of Meibomian Gland Disease, TP-04 for the treatment of rosacea and TP-05 as an oral tablet for the prevention of Lyme disease, all of which are in Phase 2.

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Tarsus Achieves Positive Topline Results in Lyme Disease Trial

Catie Corcoran

Biotech Editor