Holoclara Begins Phase 1 Trial of Worm-Derived Therapeutic HC002 in Adults

Holoclara, a biotechnology firm located in Pasadena, California, has set a precedent in the field of medical research by launching a groundbreaking first-in-human Phase 1 clinical trial. This trial is aimed at assessing the safety, tolerability, and pharmacokinetics of a novel treatment, HC002, in healthy adults. HC002 is a promising, orally administered small molecule developed from unique compounds found in worms. This innovative approach by Holoclara is poised to address allergic and autoimmune disorders that have long posed challenges in the medical community.

According to Andrea Choe, M.D., Ph.D., who is both the co-founder and CEO of Holoclara, the initiation of this trial is not just an achievement for the company but also a significant advancement for medical science. The potential of HC002 to alleviate the suffering of millions of patients with chronic inflammatory diseases marks a pivotal moment in therapeutic development. Dr. Choe emphasizes the importance of these naturally occurring molecules from worms, which have evolved alongside humans to offer protection from various diseases over thousands of years. Holoclara is keen to progress not just with HC002 but also with its wider array of therapeutic projects.

The Phase 1 trial represents a meticulous process involving the completion of Holoclara’s first Good Manufacturing Practice (GMP) batch of HC002. Designed as a randomized, double-blind, placebo-controlled study, this trial will involve healthy adult volunteers who will receive the orally administered drug. The research is taking place in Australia, where Holoclara collaborates with Novotech and CMAX Clinical Research, a prominent clinical trial operator located in Adelaide, South Australia. CMAX is tasked with recruiting participants, conducting the trial, and ensuring its smooth progression. The results of this study are anticipated to be available in 2025.

Jane Kelly, CEO of CMAX Clinical Research, expressed enthusiasm about the partnership with Holoclara, highlighting that it marks the first-ever trial of worm-derived medicines developed by the company. She noted that CMAX, as one of Australia’s foremost clinical trial facilities, is well-equipped to handle early-phase and first-in-human studies, supporting innovative biotechnology ventures from across the globe.

Thomas Polasek, M.D., Ph.D., who is the Associate Medical Director at CMAX and the principal investigator of the study, praised Holoclara's revolutionary technology. He pointed out that the use of worm-derived therapeutic agents has the potential to transform global treatment strategies for inflammatory diseases. Hosting Holoclara's inaugural human trial for HC002 is regarded as a crucial milestone in delivering these groundbreaking therapies to patients worldwide.

Holoclara is at the forefront of creating orally available treatments derived from worms, specifically targeting those suffering from allergic and autoimmune conditions. The company, co-founded by Dr. Andrea Choe, leverages scientific findings on immunomodulatory molecules sourced from gut roundworms, which have shown therapeutic promise in preclinical studies for various illnesses. With a team comprised of leading experts in worm biology and biotechnology, and backed by prominent investors, Holoclara is in a strong position to exploit the healing potential of worms to tackle challenging diseases that have remained difficult to treat.