Tarsus Pharmaceuticals, Inc. Announces FDA Acceptance of Investigational New Drug Application for TP-05 for Lyme Disease Prevention
| Source: Tarsus Pharmaceuticals, Inc
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 million are at high or moderate risk for contracting the disease.
TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills ticks by blocking the parasite-specific GABA-CI channels. TP-05 is believed to be the only non-vaccine based therapeutic in development and 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. In addition to the prevention of Lyme disease, Tarsus is also exploring TP-05 for the community prevention of malaria.
Tarsus is currently conducting a pivotal trial evaluating the efficacy and safety of TP-03, a topical ophthalmic formulation of lotilaner, for the treatment of Demodex blepharitis, a common ocular condition caused by an infestation of Demodex mites.
TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills parasites by inhibiting parasite-specific GABA-Cl channels. Tarsus is studying TP-05 for the prevention of Lyme disease. In July of 2021, 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. In addition to Lyme disease, Tarsus is also exploring TP-05 for the community prevention of malaria.
About Lyme Disease
Lyme disease is the most common vector-borne disease in the United States, transmitted to humans after the bite of a blacklegged tick infected by the bacterium Borrelia burgdorferi. Over 30 million Americans are at high or moderate risk of contracting Lyme disease and there are approximately 300,000 – 400,000 cases in the U.S. each year. People who spend extended amounts of time outdoors in wooded, grassy areas are at higher risk of getting the infection. Data from the Centers for Disease Control (CDC) shows that the risk of Lyme disease is spreading to new geographical areas, resulting in a significant need for prophylactic solutions. Currently, there are no FDA-approved pharmacological prophylactic options for Lyme disease.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Its lead product candidate, TP-03, is a novel therapeutic in a pivotal Phase 2b/3 trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease.
Westwicke Partners, an ICR company
For more on Lotilaner:
- https://vetmed.illinois.edu/pet_column/fda-alert-on-flea-medications/ Only medications in the isoxazoline class of flea and tick medications are under investigation at this time. This includes Bravecto, Nexgard, Credelio, and Simparica (brand names for fluralaner, afoxolaner, lotilaner, and sarolaner).
- Credelio contains the ingredient, lotilaner, which is an antiparasitic drug that kills the fleas and ticks that live on your pet’s body surface. Lotilaner blocks the transfer of chloride ions from passing through cell membranes, which causes uncontrolled neuromuscular activity and results in the death of fleas and ticks. Credelio starts killing fleas within 4 hours of administration and kills over 99% of fleas within 8 hours of administration. Credelio starts killing ticks* in 4 hours and 98.7% killed within 8 hours. *(Ixodes ricinus) Source
- https://ivcjournal.com/isoxazoline-flea-and-tick/ On September 20, 2018, the U.S. Food and Drug Administration (FDA) warned animal caregivers and veterinarians about the risk of serious neurologic events, including seizures, muscle tremors and ataxia, in dogs and cats treated with certain flea and tick medications. The warning applies to medications in the isoxazoline class — specifically, NexGard (afoxalaner), Bravecto (fluralaner), Simparica (sarolaner) and Credelio (lotilaner). The FDA updated their release on April 22, 2019 to include another recently-approved product in the isoxazoline class — namely, Revolution Plus (selamectin and sarolaner topical solution). The isoxazoline class encompasses a group of azolyl phenyl chemical compounds originally developed as parasiticides about 20 years ago. They are now widely used around the world. Adverse reactions to these compounds appear to affect animals randomly, although those with certain chronic diseases, the young and elderly, and animals that are immune-compromised or have the genetic mutation of the MDR1 gene are at higher risk.