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Tarsus Pharmaceuticals, Inc. Initiates Phase 1 Callisto Trial of TP-05, a Novel, Oral, Non-Vaccine Therapeutic for the Prevention of Lyme Disease
More than 30 million Americans at risk for Lyme disease exposure, which can result in severe neurological and other debilitating symptoms First participants
About this update from Tarsus Pharmaceuticals, Inc.
[{"type":"text","content":"More than 30 million Americans at risk for Lyme disease exposure, which can result in severe neurological and other debilitating symptoms First participants dosed in single ascending dose and multiple ascending dose (SAD/MAD) trial to evaluate safety, tolerability and pharmacokinetics of TP-05 in healthy volunteers TP-05 is designed to kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease IRVINE, Calif., June 16, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that it has initiated dosing participants in its first clinical trial for TP-05, a novel, oral, non-vaccine therapeutic for the prevention of Lyme disease. The Phase 1 Callisto trial is a single ascending dose and multiple ascending dose trial to evaluate the safety, tolerability and pharmacokinetics (PK) of TP-05 in healthy volunteers. 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, transmitted to humans through the infection of the bacterium Borrelia burgdorferi following the bite of a tick vector. TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills ticks by selectively inhibiting parasite-specific GABA-Cl channels. TP-05 is believed to be the only non-vaccine, drug-based, preventive therapeutic in development that targets the ticks, and potentially prevents disease transmission. It is designed to rapidly provide systemic blood levels of lotilaner and kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease. “Millions of Americans are at high or moderate risk of contracting Lyme disease, which can lead to significant and long-term health problems. There is a great need for a preventive solution that has the potential to kill the tick before it transmits disease,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “Initiating the TP-05 Phase 1 Callisto trial is an important s...