NewsDesk @bactiman63

Tarsus Pharmaceuticals, Inc. announced positive topline results from the completed Phase 1b Callisto trial and the enrollment of the first subject in the Carpo Phase 2a trial. The Callisto and Carpo trials are designed to evaluate TP-05, a novel investigative oral therapeutic for the potential prevention of Lyme disease.

Black-legged tick
Ixodes scapularis, a Black-legged tick/CDC

The Callisto trial was a randomized, double-blind, single- and multiple-ascending dose study that evaluated the safety, tolerability, food-effect, and pharmacokinetics (PK) of TP-05 in healthy subjects. Results from the trial showed that TP-05 was well tolerated with no dose-related or drug-related serious adverse events. Pharmacokinetic data from the trial demonstrated rapid absorption and an extended half-life of TP-05 that potentially supports a monthly, or less frequent therapy regimen, supporting its potential as a convenient, rapid onset, prophylactic therapy for Lyme disease. Additionally, exploratory ex-vivo tick kill modeling utilizing serum from TP-05-treated subjects demonstrated potent, rapid killing of adult and nymph ticks.

Tarsus also announced the enrollment of the first patient in the Carpo trial, evaluating TP-05 for the potential prevention of Lyme disease in humans. The Carpo trial is a randomized, double-blind trial that will evaluate the efficacy of TP-05 in killing sterile, non-disease carrying ticks after they have attached to the skin of healthy volunteers, as well as confirm the safety, tolerability, and blood concentration of TP-05.

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TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-CI 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 a growing global health concern that may result in serious, often irreversible sequelae if left untreated,” said José Trevejo, MD, PhD, Chief Medical Officer of Tarsus. “As the risk of infection extends into new regions and as overall prevalence grows, identifying a solution to prevent transmission becomes paramount. Tarsus is committed to addressing large, underserved disease areas with unique solutions and our TP-05 investigational program embodies this commitment, as there are no current preventative options for this important disease.”

There are currently no U.S. Food and Drug Administration (FDA)-approved pharmacological prophylactic options for Lyme disease, which is the most common vector-borne disease in the United States. Lyme disease is transmitted through Borrelia burgdorferi infection following the bite of a tick vector. Over 30 million Americans are at high or moderate risk of contracting Lyme disease and there are approximately 300,000 – 400,000 cases in the U.S. each year.