Positive Phase 2a Carpo Trial Outcomes for TP-05 Lyme Disease Prevention

Tarsus Pharmaceuticals, Inc. has reported encouraging preliminary findings from the Phase 2a Carpo trial for TP-05 (lotilaner), a new oral treatment aimed at preventing Lyme disease. The study was a randomized, double-blind, and placebo-controlled trial that assessed the efficacy of a single dose of TP-05 in eliminating ticks from human subjects. The trial involved placing sterile, non-pathogenic nymphal ticks on the skin of volunteers on two separate occasions, and the ticks' mortality was evaluated within 24 hours post-attachment. The results showed that both high and low doses of TP-05 significantly outperformed the placebo in killing ticks, with a mean mortality rate of 97.0% and 92.0% respectively on Day 1, and 89.0% and 91.0% on Day 30.

The significance of these findings lies in the potential of TP-05 to provide a rapid and durable defense against tick-borne diseases, offering an alternative to vaccines. Lyme disease, the most prevalent vector-borne illness in the U.S., is transmitted by ticks infected with Borrelia burgdorferi. It can lead to severe symptoms and complications, with an estimated 300,000 to 400,000 new cases annually in the country. The disease often goes unnoticed due to the unobtrusive nature of tick bites, particularly in those who spend time outdoors in areas where ticks are common.

TP-05 is an oral systemic formulation of lotilaner, which selectively targets parasite-specific GABA-Cl channels. It is considered a non-vaccine, drug-based preventative therapeutic that could potentially halt the transmission of Lyme disease by killing ticks. The development of such a treatment is crucial given the increasing prevalence of Lyme disease and its spread to new geographical regions.

Tarsus Pharmaceuticals is dedicated to addressing unmet medical needs through the application of scientific advancements and innovative technologies, with a focus on eye care, dermatology, and infectious disease prevention. The company's pipeline includes several treatments for diseases with significant unmet needs, such as XDEMVY® for Demodex blepharitis, TP-03 for Meibomian Gland Disease, TP-04 for rosacea, and TP-05 for Lyme disease prevention, all of which are currently in Phase 2 of development.

The company's CEO and Chairman, Bobby Azamian, M.D., Ph.D., expressed optimism about the potential of TP-05 to address the root cause of Lyme disease by targeting the ticks that transmit the bacteria. Dr. Linden Hu, Principal Investigator for the Carpo trial and a prominent figure in immunology, emphasized the alarming growth of tick-borne diseases and the importance of TP-05's potential to offer rapid and enduring protection.

The development of TP-05 and its successful trial outcomes are steps towards providing a much-needed prophylactic solution for Lyme disease, which currently lacks FDA-approved pharmacological preventative options. The positive results from the Carpo trial indicate a promising direction for on-demand oral treatments that could revolutionize the prevention of Lyme disease and other tick-borne infections.