Worcester – New data from UMass Chan Medical School show the potential for the first drug to prevent Lyme disease, a disease that afflicts tens of thousands of people in the United States each year.
The final results of the first phase of human clinical trials arrived in February. They have shown that a human monoclonal antibody developed by UMass Chan’s MassBiologics is safe, remains in the bloodstream for months, and provides adequate protection against tick bites.
Dr. Mark Klempner, Professor of Medicine at UMass Chan, said:
No adverse health effects were reported among the 44 participants in the Phase 1 trial, Klempner said, noting skin irritation at the time of injection. The drug also stays in his body for six to seven months, and the research team thought that one dose could protect her for an entire tick season.
The next step is a Phase 2/3 clinical trial, potentially involving up to 4,000 volunteers, half of whom will receive the antibody and the rest a placebo. Counties with a high incidence of Lyme disease are eligible for enrolled participants.
UMass Chan is working with another entity to advance this drug to Phase 2/3. The agency sponsors the exam, provides financial support, and sets the standards for success. Once his 80% protection against Lyme disease is achieved, the trial is likely to be considered successful, Klempner said.
Klempner said trials will begin this year, and if the results are approved by the U.S. Food and Drug Administration, the antibody could be commercially available to the general public in 2025.
Antibody function
Simply put, it traps bacteria in the gut of ticks so that they cannot infect humans.
Unlike vaccines, which trigger the body’s immune system to attack foreign substances, pre-exposure prophylaxis is a single human anti-Lyme antibody that is injected into the human body.
The time series works like this: Ticks sink their jaws into human flesh and suck blood containing antibodies. The drug then acts, neutralizing the harmful bacteria in the tick’s gut, trapping or killing it, and preventing it from coming out of the tick’s saliva while its jaws are anchored to the human body. Without antibodies, bacteria in saliva can enter the bloodstream and cause Lyme disease.
The risk of Lyme disease increases in the spring and fall when ticks are not present. Symptoms include rash, fever, muscle and joint pain. If undetected, the disease can develop into serious and long-term complications, such as arrhythmias and inflammation of the brain and spinal cord.
Antibody therapy is the current treatment.
competition
Two companies joined forces and were able to stop UMass Chan. Pfizer and her Valneva are in the final phase 3 of human clinical trials to develop a vaccine to prevent the disease.
In February, Pfizer reported that it had reduced a significant percentage of U.S. trial participants for violations of good clinical practice at certain trial sites operated by third-party operators. Pfizer says the move has nothing to do with safety concerns about the vaccine under investigation, and in 2025 he aims to submit an application for approval to the FDA.
Even if UMass Chan wasn’t the first to market its monoclonal antibody, Klempner believes there is still demand for the drug.
“We weren’t the first to market, but we think there is space. There are benefits,” says Klempner.
numbers
The number of people with Lyme disease in the United States varies greatly.
According to the US Centers for Disease Control and Prevention, 476,000 Americans are diagnosed and treated for the disease each year, based on insurance records. However, the CDC notes that the number of reported cases has dropped to 35,000 annually, based on information provided by state and local public health departments.
According to the CDC, Massachusetts is one of the top 10 states for Lyme disease cases. Between 2012 and 2014, Massachusetts reported more than 5,000 cases annually.
State public health departments have reportedly contested the lower numbers, arguing that the CDC only allows states to count positive cases for both laboratory tests and clinical diagnoses. Did. The DPH removed the clinical diagnosis part because it took too much time and resources and claimed the actual number of cases was much higher.
According to DPH, Worcester County reported 277 tick-borne illnesses from hospital emergency rooms in 2019; 188 in 2020; 214 in 2021; By February, there were four cases.
A spokesman for the city of Worcester said the number of recent Lyme disease cases has been very low, with one each in 2019 and 2020, and no cases in 2021 and 2022.
Please contact Henry Schwan at [email protected]. Follow him on Twitter @henrytelegram
