Holoclara Chooses Eosinophilic Esophagitis for Lead Worm-Derived Therapy HC002

Holoclara, a biotechnology company based in Pasadena, California, is at the forefront of developing worm-derived treatments for allergic and autoimmune disorders. Recently, the company has highlighted eosinophilic esophagitis (EoE) as the primary condition for its innovative investigational medicine, HC002, with a vision to extend its applications to other medical conditions in the future. At present, Holoclara is conducting a Phase 1 clinical trial that examines the safety, tolerability, and pharmacokinetics of HC002 in healthy individuals.

Eosinophilic esophagitis is a persistent inflammatory condition marked by the accumulation of eosinophil, a type of white blood cell, within the esophagus. This buildup often occurs as a response to allergens and can harm esophageal tissues, resulting in symptoms such as difficulty swallowing, chest and abdominal pain, vomiting, and diminished appetite.

Previously, EoE was classified as an orphan disease, believed to affect fewer than 200,000 people in the United States. However, newer research suggests this figure is significantly underestimated. The actual prevalence is closer to 1 in 700, translating to approximately half a million individuals in the U.S. Over the past two decades, this represents a dramatic five-fold increase, making EoE the second most common esophageal condition in the country. The financial burden associated with EoE is substantial, with annual costs estimated at $1.3 billion. While the diagnosis of EoE can be effective, overlapping conditions, coexisting diseases, and delayed diagnosis after the onset of symptoms often result in frequent misdiagnoses and a lack of timely treatment.

Holoclara’s co-founder and CEO, Andrea Choe, M.D., Ph.D., emphasized the growing prevalence of eosinophilic esophagitis worldwide and the lack of effective treatments. Choe stated, "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."

Evan S. Dellon, M.D., MPH, a Professor of Medicine specializing in gastroenterology and hepatology at the University of North Carolina School of Medicine, also stressed the increasing global prevalence of EoE. He noted that the condition’s growing impact presents substantial unmet needs for patients. Dellon expressed optimism about further clinical investigations of Holoclara’s HC002, which utilizes worm-derived molecules to influence disease activity.

HC002, the investigational drug at the center of Holoclara’s research, is an orally bioavailable small molecule derived from worm molecules. These molecules were developed using the company's proprietary discovery methods. Holoclara is advancing into Phase 1 trials of HC002 and plans to conduct proof-of-concept clinical studies in the future. Given the competitive landscape, where only two FDA-approved treatments are currently available for EoE, Holoclara's worm-derived therapies aim to alleviate the symptoms for an increasing population of EoE patients and potentially address other related conditions.

Founded by Andrea Choe, Holoclara stands out as the first biotech company to develop worm-derived, orally available therapies tailored for individuals with allergic and autoimmune diseases. The company's approach involves mining immunomodulatory molecules from gut roundworms, building on extensive preclinical data that supports their therapeutic potential across various diseases. With a team of renowned experts in worm biology and biotechnology development, and support from leading life sciences and technology investors, Holoclara is well-positioned to unlock the therapeutic benefits of worms for diseases that have been challenging to treat historically.