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Tarsus Announces Positive Topline Data from Phase 1b Callisto Trial and Initiates Phase 2a Carpo Human Tick Kill Trial Evaluating TP-05, A Novel, Oral Therapeutic for the Prevention of Lyme Disease
Positive Phase 1b Callisto data shows that TP-05 is well tolerated and safety data supports progression to Phase 2a Phase 2a Carpo trial to evaluate the
About this update from Tarsus Pharmaceuticals, Inc.
[{"type":"text","content":"Positive Phase 1b Callisto data shows that TP-05 is well tolerated and safety data supports progression to Phase 2a Phase 2a Carpo trial to evaluate the safety, tolerability, and proof-of-activity of TP-05 in healthy subjects TP-05 designed to be an on-demand, long-acting prophylactic treatment that targets and eradicates ticks that transmit Lyme disease IRVINE, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), 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 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. 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. 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 potentiall...