IRVINE, Calif. - Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) has announced that its Phase 2a Carpo trial of TP-05, an investigational oral therapeutic aimed at preventing Lyme disease, has yielded positive topline results. The trial, which was randomized, double-blind, and placebo-controlled, assessed the efficacy of TP-05 in killing ticks attached to human subjects.
The study involved placing non-pathogenic nymphal ticks on the skin of healthy volunteers and measuring tick mortality within 24 hours of attachment. Results showed that both high and low doses of TP-05 led to statistically significant tick mortality rates compared to the placebo. Specifically, after the initial tick challenge, the average tick mortality was 97.0% for the high dose and 92.0% for the low dose, versus just 5.0% for the placebo. At the 30-day mark, mortality rates were 89.0% and 91.0% for high and low doses, respectively, compared to 9.0% for the placebo.
TP-05 was generally well-tolerated with no significant differences in tick mortality between the two treatment arms. The trial's principal investigator, Dr. Linden Hu of Tufts University School of Medicine, expressed optimism about TP-05's potential to provide rapid and durable protection against multiple tick-borne diseases.
Lyme disease, caused by Borrelia burgdorferi infection from tick bites, is the most prevalent vector-borne disease in the U.S., with up to 400,000 cases annually. It can lead to serious, long-term health issues, and there are currently no FDA-approved pharmacological prophylactic options for the disease.
Tarsus Pharmaceuticals focuses on addressing unmet medical needs, starting with eye care, and is developing a range of treatments for various conditions, including infectious disease prevention. TP-05, an oral systemic formulation of the anti-parasitic agent lotilaner, is part of this pipeline.
The company's CEO, Dr. Bobby Azamian, highlighted the growing public health concern posed by Lyme disease and the potential of TP-05 to revolutionize prevention by addressing the root cause—the ticks that transmit the disease.
This news is based on a press release statement, and further details regarding the complete clinical results of the Carpo trial are anticipated.
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