Holoclara, a biotechnology company focused on developing worm-derived therapies, has commenced a Phase 1 clinical trial evaluating HC002, an orally bioavailable small molecule, in healthy adult volunteers. The trial aims to assess the safety, tolerability, and pharmacokinetics of HC002, which is derived from molecules identified in worms and is intended for the treatment of allergic and autoimmune disorders.
The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study. It is being conducted in Australia in partnership with Novotech and CMAX Clinical Research. CMAX will manage participant recruitment, enrollment, and study execution. Initial results from the study are anticipated in 2025. Full details of the study are available at ClinicalTrials.gov (NCT06670274).
Novel Approach to Inflammatory Disease
HC002 represents a novel therapeutic approach by harnessing molecules from worms, which have co-evolved with humans and may offer protection against disease. According to Andrea Choe, M.D., Ph.D., co-founder and CEO of Holoclara, this trial is a "first in humans and in medicine" that could provide significant relief to patients with chronic inflammatory diseases.
Trial Design and Execution
The Phase 1 trial utilizes a Good Manufacturing Practice (GMP) batch of HC002. The study design involves oral administration of HC002 to healthy adult volunteers. The trial is being conducted in Australia, leveraging the expertise of CMAX Clinical Research, an experienced clinical trial operator for early-phase studies.
Jane Kelly, CEO of CMAX Clinical Research, expressed enthusiasm for partnering with Holoclara on this first-in-human trial. Thomas Polasek, M.D., Ph.D., Associate Medical Director at CMAX and principal investigator for the study, highlighted the potential global impact of this technology on treating inflammatory diseases.
