US-based biotechnology company HealthBio has initiated a multi-centre clinical trial, HBT-002, to assess its lead compound Inflamexa in adult patients with post-treatment Lyme disease syndrome (PTLDS).
Designated under IND185316, the double-blind, placebo-controlled study plans to enrol around 252 participants across at least six sites at major medical centres in US regions where Lyme disease is endemic.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Enrolled subjects will be randomised in equal numbers to receive either the combination therapy or matching placebos for a 12-week course.
Investigators will assess the primary endpoint, fatigue, at week 24 utilising the modified Fatigue Severity Scale (FSS-11), enabling observation beyond the active treatment window.
Secondary measures will monitor fatigue at week 12, quality of life, overall symptom burden, safety, and physical, mental, and social health. The protocol also includes exploratory evaluations of immune biomarkers.
The study follows research conducted by HealthBio and academic collaborators, who examined persistent Borrelia burgdorferi proteins in white blood cells known as monocytes.
In a recently posted preprint, mass spectrometry identified two bacterial proteins, FlaB and OspC, in CD14-positive and CD16-positive monocytes isolated from patients with ongoing symptoms months to years following antibiotic therapy.
These proteins were present alongside inflammatory gene-expression patterns without active bacterial transcription.
HealthBio co-founder and CEO Bruce Patterson said: “These findings give us a biological hypothesis to investigate whether bacterial material remaining after treatment contributes to persistent immune dysfunction.
“Our planned randomised, placebo-controlled trial is designed to evaluate whether targeting immune pathways with Inflamexa can improve symptoms in people with PTLDS. Connecting immunological discoveries with rigorous clinical evaluation is central to HealthBio’s approach.”
The trial also builds upon HealthBio’s ongoing assessment of the same patented immune-reset approach in Long Covid.
The company focuses on developing diagnostic and therapeutic methods for chronic inflammatory and immune-mediated conditions through machine learning and precision diagnostics, targeting diseases such as Chronic Lyme Disease, Long COVID, and Myalgic Encephalomyelitis-Chronic Fatigue Syndrome (ME-CFS).
