HealthBio Initiates Randomized Clinical Trial Evaluating Inflamexa™ for Post-Treatment Lyme Disease Syndrome

• Multi-center, placebo-controlled study will assess the combination in adults with persistent symptoms after antibiotic treatment for Lyme disease
  
  
• Trial design informed by recent research linking residual bacterial proteins to immune dysregulation in a subset of patients

HAYWARD, Calif., Oct. 21, 2026 /PRNewswire/ -- HealthBio, Inc., a biotechnology company developing novel immune-reset therapies for inflammatory disease, today announced the initiation of its multi-center, randomized, double-blind, placebo-controlled clinical trial (HBT-002; IND185316) evaluating its lead compound Inflamexa™, in adults with post-treatment Lyme disease syndrome (PTLDS).

The study will enroll approximately 252 participants across at least six U.S. sites, which include major medical centers in Lyme endemic regions. Participants will be randomized in equal numbers to receive the combination or matching placebos for 12 weeks. The primary endpoint is fatigue at week 24, assessed using the modified Fatigue Severity Scale (FSS-11), allowing evaluation beyond the treatment period. Secondary assessments will examine fatigue at week 12, quality of life, overall symptom burden, physical, mental, and social health, and safety. Exploratory analyses will evaluate immune biomarkers. The trial is not yet open and is not recruiting participants.

The trial builds on HealthBio's ongoing evaluation of the same patented immune reset therapy in Long COVID and on a recently posted preprint (https://doi.org/10.64898/2026.09.24.26363601) examining persistent Borrelia burgdorferi proteins in white blood cells called monocytes in patients with PTLDS. That work detected bacterial proteins months to years after antibiotic treatment in the absence of active bacterial transcription and identified associated inflammatory gene-expression patterns.

New Insights into Immune Dysregulation After Lyme Disease

Researchers from HealthBio and academic collaborators analyzed isolated CD14-positive and CD16-positive monocytes from patients with persistent symptoms following antibiotic Lyme disease treatment. Mass spectrometry detected two bacterial proteins, FlaB and OspC, in samples from multiple participants, months to years after antibiotic treatment.

"These findings give us a biological hypothesis to investigate, whether bacterial material remaining after treatment contributes to persistent immune dysfunction," said Bruce K. Patterson, M.D., co-founder and chief executive officer of HealthBio. "Our planned randomized, 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."

About HealthBio

HealthBio, Inc., a biotechnology company developing diagnostic and therapeutic approaches for chronic inflammatory and immune-mediated diseases. Its research examines persistent immune dysregulation and translates biological insights into potential treatments for clinical evaluation using machine learning and AI-based precision diagnostics. HealthBio is initially focused on precision immune modulation of neglected diseases, including Long COVID, Myalgic Encephalomyelitis-Chronic Fatigue Syndrome (ME-CFS) and Chronic Lyme Disease. The company aims to improve diagnosis, advance new science, and innovate new medicines for these historically minimally characterized diseases. For more information or investment inquiries, please contact us at www.healthbio.com.

Investor Contact:
Brian Brothen
[email protected]

SOURCE Healthbio Inc