Business
Tarsus Pharmaceuticals, Inc. Announces FDA Acceptance of Investigational New Drug Application for TP-05 for Lyme Disease Prevention
Novel candidate in development aims to be first approved non-vaccine therapeutic for Lyme disease prevention Allows initiation of Phase 1 study to evaluate
About this update from Tarsus Pharmaceuticals, Inc.
[{"type":"text","content":"Novel candidate in development aims to be first approved non-vaccine therapeutic for Lyme disease prevention Allows initiation of Phase 1 study to evaluate safety, pharmacokinetics, and dosing More than 30 million Americans at risk for Lyme disease exposure, which can result in severe neurological and other debilitating symptoms IRVINE, Calif., May 04, 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 the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease. With this IND acceptance, Tarsus will initiate a Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of TP-05 in healthy volunteers. Study initiation is anticipated in July. “We are pleased that the FDA has accepted the IND for TP-05, which is an important milestone in our pipeline development. Currently, there are no approved pharmacological prophylactic options for tick kill and preventing transmission of Lyme disease, which has the potential to cause severe, often debilitating symptoms with permanent and irreversible damage,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “There is a significant unmet need for a therapeutic to quickly and reliably prevent this disease that can lead to poor outcomes for so many people. We look forward to initiating our clinical development program for TP-05 and advancing the path for this much-needed therapeutic for Lyme disease prevention.” Lyme disease is transmitted to humans after the bite of a blacklegged tick infected with the Borrelia bacteria. It is the most common vector-borne disease in the United States and 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 impacts more than 300,000 people in the U.S. each year and over 30 ...