Innovating at the Intersection of Science, Medicine and Technology

Clostridioides difficile (CD) is the leading cause of hospital- and community-acquired diarrhea in the U.S., with over 485,000 cases and 25,000 deaths annually. Drug-resistant strains like B1/NAP1/027 have rendered current therapies (Metronidazole, Vancomycin, Fidaxomicin) increasingly ineffective. Fecal Microbiota Transplant, the last resort for resulting recurrent CDIs, had an FDA warning of “potential risk of life-threatening antibiotic-resistant infections”.

‍

Supported by Elona Pharmaceuticals, KamTek’s microbiology labs investigated antimicrobial selectivity and discovered a potent, narrow-spectrum activity of Clofazimine against C. difficile, sparing the rest of the gut microbiota. These findings led to:

• Patent filings for novel uses of Clofazimine
• In vivo studies through SBIR-funded animal studies
• Foundation for EK101’s development

A Potential Low-Relapse Therapy for a Major Public Health Crisis

With support from a Phase I SBIR award from NIAID/NIH and private investment from Elona Pharmaceuticals, KamTek developed EK101—an enteric-coated Clofazimine (CFZ) formulation designed for colon-targeted delivery:

• Stable at pH 2.0, minimizing degradation in the stomach
• Delayed release at pH 6.0–6.5, bypassing the small intestine
• Rapid dissolution at pH 7.0, maximizing colonic activity with minimal systemic absorption

This formulation addresses relapse-prone CDI by acting where CD thrives—the colon—while preserving the gut microbiota.

EK101 is protected by three U.S. patents and continues to represent a possible, low-relapse alternative to current CDI treatments.

KamTek’s EBV (Epstein-Barr Virus) transformation service traces its roots to a 1983 SBIR Phase I award originally granted to Braton Biotech. Dr. Sharan VedBrat, then a key scientific contributor, took over the project — ultimately helping transition the technology into KamTek’s commercial portfolio.

• HLA-typed EBV-transformed B-cell lines for the U.S FDA, providing a renewable source of reference DNA for standardized HLA genotyping panels—supporting both regulatory and diagnostic labs.
• Trisomy 18 cell lines from cord blood for Ariosa Diagnostics (now Roche Sequencing Solutions)—a foundational step for their Harmony™ Prenatal Test, a widely adopted, non-invasive blood screening tool. KamTek continues to support Roche in expanding these tests globally by providing new cell lines and DNA reference materials.

Infrastructure and Compliance from Discovery to FDA Approval

KamTek’s molecular diagnostics legacy includes:

• SBIR-funded Phase I & II development of DNA probes and PCR tests for Leishmania
• Evolution to custom microarrays incorporating DNA, protein, and glycan probes
• Extensive collaborations with NCI, WRAIR, and U.S. Navy, generating high-quality, peer-reviewed publications

KamTek, in collaboration with Dr. Raja Mazumder’s lab at George Washington Hospital, studied how gut microbiota influences health and treatment outcomes for Clostridioides difficile-associated disease (CDAD).
We analyzed 160 fecal samples from healthy individuals—comparing those who use artificial sweeteners to those who don’t—using NGS-based metagenomic analysis. The goal: to understand how dietary factors impact microbiome balance and readiness for CDAD therapies.

KamTek has initiated exploratory work to understand the genetic variability of chronic Hepatitis C virus (HCV) infections and how it relates to therapeutic response—adding another layer to our commitment to infectious disease R&D.