• A novel, investigational medicine harnessing the therapeutic potential of worms currently in Phase 1 clinical trial
• Company’s selection of eosinophilic esophagitis for its lead indication to usher in a new era for allergic and autoimmune disease

Holoclara, a biotechnology company pioneering the development of worm-derived therapies for allergic and autoimmune disorders, today announced the selection of eosinophilic esophagitis (EoE) as its lead indication for its novel, investigational medicine, HC002, with the plan to expand to other indications. The company is currently conducting a Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics of HC002 in healthy adults.

EoE is a chronic inflammatory disorder characterized by elevated levels of eosinophil, a type of white blood cell, in the esophagus. Eosinophil can build up in reaction to an allergen, leading to damage of the esophageal tissue and potentially cause difficulty swallowing, chest and abdominal pain, vomiting, and loss of appetite.

Historically, EoE has been considered an orphan disease affecting fewer than 200,000 individuals in the United States. Recent studies report that this is severely underestimated with an actual prevalence of 1 in 700, or half a million people in the United States. This dramatic, five-fold increase in prevalence over the past two decades makes EoE the second most common esophageal disease with estimated annual costs totaling $1.3 billion. Diagnosis of EoE is effective but coexisting conditions, comorbidities, and delayed diagnosis following symptom onset often result in frequent misdiagnoses and lack of timely treatment.

“Eosinophilic esophagitis is becoming increasingly common all over the world, yet remains fundamentally neglected when it comes to effective, tolerable treatments,” said Andrea Choe, M.D., Ph.D., co-founder and Chief Executive Officer of Holoclara. “From day one, Holoclara has been committed to pioneering breakthrough solutions for underserved patient communities, and we are advancing our first program to address eosinophilic esophagitis and exploring other critical indications that will pave a new path for worm-derived therapeutics and allergic and autoimmune disorders alike.”

“The global prevalence of eosinophilic esophagitis has more than doubled over the prior decade, leading to a significant burden of disease,” said Evan S. Dellon, M.D., MPH, Professor of Medicine in the Division of Gastroenterology and Hepatology, and Director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, and co-author of a new publication highlighting the rapidly increasing EoE prevalence in the U.S. “As this chronic condition becomes more widespread and the unmet needs of patients grow, I look forward to further clinical investigation of Holoclara’s drug, HC002, leveraging worm-derived molecules to modulate disease activity.”

HC002 is an investigational, orally bioavailable small molecule discovered from molecules identified in worms and developed with the company’s proprietary discovery engine. Holoclara is entering its Phase 1 trial of HC002 with future plans to embark on proof-of-concept clinical studies. In a competitive landscape with only two FDA-approved treatments currently available, the company’s worm-derived therapies are designed to bring relief to the growing EoE patient population and beyond.

About Holoclara

Holoclara is the first biotechnology company to create orally available, worm-derived therapies designed to provide relief to millions of people living with allergic and autoimmune disease. Co-founded and led by physician-scientist Andrea Choe, Holoclara mines immunomodulatory molecules from gut roundworms, building upon decades of preclinical data proving their therapeutic efficacy across a wide range of diseases. With a team of world-renowned experts in worm biology, experience in developing biotechnologies, and the backing of leading life sciences and technology investors, Holoclara is uniquely positioned to harness the therapeutic potential of worms to address historically untreatable diseases. To learn more, visit www.holoclara.com.

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