Tarsus Announces Positive Topline Results From Phase 2a Proof-of-Concept Trial Evaluating TP-05 for the Prevention of Lyme Disease

Tarsus Pharmaceuticals, Inc. recently announced positive topline results from the Phase 2a Carpo trial evaluating TP-05 (lotilaner), a novel, investigational oral therapeutic for the prevention of Lyme disease.

In this randomized, double-blind, placebo-controlled trial, the ability of TP-05 to kill ticks attached to subjects with a single treatment of TP-05 (low or high dose) was evaluated compared to placebo. Sterile, non-pathogenic nymphal ticks were placed on the skin of healthy human volunteers at two separate instances (one day prior to dosing and on Day 30 after dosing). Tick mortality was evaluated within 24 hours of attachment after each placement. 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.

Both the high and low doses of TP-05 demonstrated a statistically significant benefit in killing ticks compared to placebo. Specifically, after the Day 1 tick challenge, mean tick mortality was 97.0% (± 1.4 standard error, SE) and 92.0% (± 6.3 SE) for the high and low doses of TP-05, respectively, compared to only 5.0% (± 2.5 SE) for placebo (p < 0.0001).

Similarly, at the 30-day challenge, mean tick mortality at 24 hours after placement was 89.0% (± 11.1 SE) and 91.0% (± 6.1 SE) for the high and low doses of TP-05, respectively, compared to only 9.0% (± 8.0 SE) for placebo (p<0.001). No statistically significant differences in tick mortality were observed between the two TP-05 treatment arms, and TP-05 was generally well tolerated.

“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 US healthcare system,” said Bobby Azamian, MD, PhD, 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.”

“The risk of infection from tick-borne diseases, such as Lyme disease and other serious infections, is growing at an alarming rate, and the consequences can be debilitating and long-lasting,” said Linden Hu, MD, the Paul and Elaine Chervinsky Professor in Immunology at Tufts University School of Medicine and Principal Investigator for the Carpo trial. “The tick-kill rates seen at Day 1 and Day 30 suggest that TP-05 may have the potential to provide both rapid and durable protection against multiple tick-borne diseases, which would be a welcome alternative to vaccines in the prevention armamentarium.”

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

Lyme disease is the most common vector-borne disease in the US, transmitted to humans by Borrelia burgdorferi infection following the bite of a tick vector. Over 30 million Americans are considered to be at high or moderate risk of contracting Lyme disease, and there are approximately 300,000-400,000 cases in the US each year. Lyme disease can potentially cause severe, often debilitating symptoms with permanent and irreversible damage. The disease can result in inflammation, nerve, joint and muscle pain and swelling, numbness, shortness of breath and – in severe cases – neurological complications such as facial palsy, vision issues and meningitis, including severe headaches and neck stiffness, as well as cardiac complications. Lyme disease can often go undetected and untreated because the ticks are not always noticed before they transmit the disease. People who spend extended amounts of time outdoors in wooded, grassy areas are at higher risk of Lyme disease. Data from the Centers for Disease Control and Prevention (CDC) show that the risk of Lyme disease is spreading to new geographical areas, resulting in a significant need for prophylactic solutions. Currently, there are no FDA-approved pharmacological prophylactic options for Lyme disease.

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 US 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.