Benzinga | Jun 16, 2021 04:16PM EDT

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 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 step toward potentially offering a fast-onset and long-acting, oral, non-vaccine therapeutic to help protect those who are at risk for this potentially devastating disease."

The Callisto trial intends to enroll healthy volunteers and evaluate a wide range of doses of TP-05 in the single dose phase. The multiple dose phase is planned to evaluate different doses of TP-05, each dosed periodically, and determined based on the single dose phase data. In addition to safety assessment, the systemic PK profile of TP-05, including blood levels and epidermal levels, will be assessed to provide valuable information to design future clinical studies and help facilitate exploratory research. The results of this Phase 1 trial are also expected to inform future work on TP-05 for malaria prevention.

"We are evaluating a broad range of doses in this trial to identify the optimal dose to progress to the next phase of research as quickly as possible," said Sesha Neervannan, Ph.D., Chief Operating Officer of Tarsus. "Advancing TP-05, our second investigational product, to the clinical phase of development is a significant milestone for Tarsus and represents our commitment to address high unmet needs by applying proven science and new technology to revolutionize treatment for patients."

Lyme disease can cause severe, often debilitating symptoms with permanent and irreversible damage. The disease can result in inflammation, nerve, joint and muscle pain and swelling, numbness, shortness of breath and -- in severe cases -- neurological complications such as facial palsy, vision issues and meningitis symptoms, including severe headaches and neck stiffness. Lyme disease can often go undetected and untreated because the ticks are not always noticed before they transmit the disease. Furthermore, symptoms of the disease are diverse and often incorrectly attributed to other conditions. Data from the Centers for Disease Control and Prevention (CDC) show that the risk of Lyme disease is spreading to new geographical areas, resulting in a significant need for prophylactic solutions.