Researchers plan clinical trial targeting chronic inflammation from Lyme disease
College Station, Texas — Chronic inflammation following Lyme disease may respond to therapy that targets inflammation custom-designed peptides, according to a team of investigators. The team has submitted a pre-Investigative New Drug (pIND) letter to the Food and Drug Administration as a step toward testing whether a novel treatment based on this model is effective.
Pending eventual approval to proceed, the team will submit a formal Investigational New Drug (IND) application. Upon approval of the IND, the team can begin clinical trials.
"As dermatologists know, a bull's eye rash following the bite of an infected tick is a defining marker for Lyme disease," says principal investigator M. Karen Newell-Rogers, Ph.D. Dr. Newell-Rogers is the Raleigh R. White Jr., Endowed Professor of Surgical Research at Scott and White Hospital of Texas Agricultural and Mechanical Health Science Center, College Station.
Lyme disease is transmitted by ticks infected with Borrelia burgdorferi. For many patients, treatment with antibiotic therapy resolves the disease, particularly when the infection is diagnosed early.
Some patients, however, develop persistent symptoms, including joint inflammation, fatigue, and, occasionally, cognitive changes. One school of thought holds that infection persists, and that long-term antibiotics will eventually resolve the infection. Another school holds that some patients are genetically susceptible to a post-infectious chronic inflammatory process that persists even where there is no overt sign of the infection.
"Our model is that there is a genetic element in determining response to infection and whether one develops chronic inflammatory symptoms," Dr. Newell-Rogers says. "We think that whether the organism is there is important, but just as important is the nature of the immune response that a person's immune system mounts in playing a role in the aftermath."
Toward that end, she and her investigative team have developed an investigational therapy, VGV-L, which is based on substituting a targeted peptide for the patient's own proinflammatory peptides. They want to know whether using the targeted peptide can dampen chronic inflammation and redirect the immune system. "If our peptide technology proves itself, we hope to diminish chronic inflammation following Lyme disease by targeting the immunogenetic response with a custom-targeted peptide therapy," Dr. Newell-Rogers says.