Tarsus Pharmaceuticals' Phase 2a Carpo trial for TP-05 (lotilaner), an oral treatment option designed to prevent Lyme disease, has shown promising results. The outcomes from the trial provide considerable proof of TP-05's effectiveness in eliminating ticks. With Lyme disease remaining a public health concern, TP-05 stands out as a preventative solution that could enhance current prevention methods and address the void in drug-based prophylaxis.
The study showed that both high and low doses of TP-05 outperformed the placebo in eliminating ticks. The average mortality rate for ticks was 97.0% with the high dose and 92.0% with the low dose after the initial exposure to ticks, in contrast to 5.0% with the placebo. At the 30-day mark, the mortality rate for ticks remained elevated for the TP-05 treatments, 89.0% for the high dose and 91.0% for the low dose, compared to the placebo, 9.0%. No noteworthy differences in the effectiveness of the two TP-05 doses were detected, and the treatment was generally well-received.
“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,” according to Bobby Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus.1
This trial entailed placing sterile, harmless nymphal ticks on the skin of healthy volunteers at 2 intervals, 1 day before administering the medication and again on Day 30 post-administration of either a low or high dose of TP-05, or a placebo. The mortality rate of the ticks was assessed within 24 hours of their attachment after each placement, importantly within the period before ticks typically transmit Lyme disease.
Main Takeaways
- The Phase 2a Carpo trial revealed that TP-05 is highly effective in killing ticks, with an impressive tick mortality rate of 97.0% and 92.0% for high and low doses after initial exposure.
- TP-05 represents a significant advancement in the prevention of Lyme disease, addressing a critical gap in drug-based prophylaxis against the disease.
- The Carpo trial also highlights the necessity for additional research to fully understand TP-05's potential in preventing Lyme disease in a real-world setting.
Although the trial outcomes appear encouraging, the research has limitations, its concentration on the efficacy of TP-05 in killing ticks rather than directly assessing its capacity to prevent Lyme disease in humans. Additionally, employing sterile, non-pathogenic nymphal ticks within a controlled setting might not accurately represent the intricacies of real-world tick encounters and the transmission patterns of Lyme disease.
The number of reported Lyme disease cases in the United States increased 68.5% over the average reported during 2017–2019; in high-incidence jurisdictions, the number of cases increased 72.9%, whereas in low-incidence jurisdictions, the number of cases increased 10.0%,” according to the CDC. “The differential increase in incidence might reflect:
- more frequent laboratory testing among older age groups.
- proportionally more disseminated illness in older age groups.
- proportionally more positive laboratory test results related to previous exposure to Borrelia burgdorferi rather than a current illness.2
Prevention Strategies include being mindful of going outside of ticks in grassy or wooded areas. Protection by treating gear with 0.5% permethrin and using EPA-approved insect repellents like DEET. Check for ticks on clothing and gear after being outdoors, use a dryer on high heat to kill ticks, and wash clothes in hot water. Shower and do a full body check for ticks within 2 hours of coming indoors to lower disease risk.2
All in all, additional research and development are required to comprehensively grasp the potential of TP-05 in preventing Lyme disease and other diseases transmitted by ticks, aiming to ultimately deliver this treatment option to patients who need it.
References
- Tarsus Announces Positive Topline Results from Carpo, a Phase 2a Proof-of-Concept “Tick-Kill” Trial Evaluating TP-05 (lotilaner) for the Prevention of Lyme Disease. Published February 22. 2024. Accessed February 26, 2024. https://ir.tarsusrx.com/news-releases/news-release-details/tarsus-announces-positive-topline-results-carpo-phase-2a-proof
- Abene, S. The Surge in Lyme Disease Reports. Published February 16, 2024. Accessed February 26, 2024. https://www.contagionlive.com/view/the-surge-in-lyme-disease-reports
