TP-05, a novel, oral therapeutic recently reported topline results from its phase 1 study.
Millions of Americans are at risk of Lyme disease and approximately 30,000 cases are diagnosed annually according to the Centers for Disease Control and Prevention (CDC). And with widespread climate change, the range of the host vector of Lyme disease, the blacklegged tick (or deer tick), has expanded into new regions in the United States as well as into Canada.
“As the risk of infection extends into new regions and as overall prevalence grows, identifying a solution to prevent transmission becomes paramount,” José Trevejo, MD, PhD, Chief Medical Officer of Tarsus Pharmaceuticals, said.
And although a long course of antibiotics can cure people with Lyme disease, some people have lingering health issues including pain, fatigue, or brain fog that can last for more than 6 months after they finish treatment. This condition is called ”Post-Treatment Lyme Disease Syndrome,” according to the CDC.
Currently, there are no FDA-approved prophylactic therapies or vaccines, there might be some hope on the horizon.
Trevejo’s Tarsus Pharmaceuticals recently reported results of its phase 1b Callisto trial, which was a randomized, double-blind, single- and multiple-ascending dose study that evaluated the safety, tolerability, food-effect, and pharmacokinetics of its novel, oral medication, 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. The trial also demonstrated rapid absorption and an extended half-life of TP-05 that potentially supports a monthly, or less frequent therapy regimen.
The company announced the enrollment of its first participant for its phase 2a trial recently.
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 potentially prevent Lyme disease transmission.
In addition, Pfizer and Valneva recently reported data on their investigational Lyme disease vaccine, VLA15, which demonstrated that its antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule. The companies are currently in a phase 3 trial for the vaccine.
With a potential successful completion of the phase 3 studies, Pfizer could submit a Biologics License Application to the FDA and Marketing Authorisation Application (MAA) to the European Medicines Agency in 2025.