Lyme disease: Novel investigative oral therapeutic trials show positive topline results


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Tarsus Pharmaceuticals, Inc. reported positive results from the completed Phase 1 Callisto trial and first subject enrollment in the Carpo Phase 2a trial. The Callisto and Carpo trials were designed to evaluate TP-05, a new investigational oral treatment for potential prevention of Lyme disease.

Ixodes scapularis, black-legged tick / CDC

The Callisto trial was a randomized, double-blind, single-track, multi-boarding study to evaluate the safety, tolerability, nutritional effect, and pharmacokinetics (PK) of TP-05 in healthy subjects. Trial results showed that TP-05 was well tolerated with no serious dose-related or drug-related adverse events. Pharmacokinetic data from the trial demonstrated rapid absorption and an extended half-life of TP-05 which likely supports a monthly or less frequent treatment regimen, supporting its potential as an appropriate, rapid-onset prophylaxis for Lyme disease. In addition, exploratory modeling of ex vivo tick killing using serum from subjects treated with TP-05 demonstrated potent and rapid killing of adult ticks and nymphs.

Tarsus also announced the first patient enrollment in the Carpo trial, evaluating TP-05 for 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-pathogenic ticks after they attach 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 Lutelaner, a well-characterized antiparasitic agent that selectively inhibits parasite-specific GABA-CI channels. TP-05 is believed to be the only non-vaccine, drug-based preventative developed to kill ticks to prevent Lyme disease transmission.

“Lyme disease is a growing global health concern that, if left untreated, can lead to serious, often irreversible complications,” said Jose Trevejo, MD, PhD, chief medical officer of Tarsus. “As the risk of infection spreads to new areas and as the overall spread grows, identifying a solution to prevent transmission becomes critical. Tarsus is committed to addressing large disadvantaged disease areas with unique solutions, and our investigational program TP-05 exemplifies this commitment, as there are no current prevention options. This disease is important.”

There are currently no FDA-approved drug prevention options for Lyme disease, the most common vector-borne disease in the United States. Lyme disease is transmitted through Borrelia burgdorferi Infection after a tick vector bite. More than 30 million Americans are at high or intermediate risk of getting Lyme disease and there are approximately 300,000-400,000 cases in the United States each year.

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