First biotechnology company harnessing the therapeutic potential of worms into orally available therapies to test safety and tolerability of HC002 in first-in-human study

Holoclara, a biotechnology company pioneering the development of worm-derived therapies for allergic and autoimmune disorders, today announced the launch of a first-in-human Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of HC002 in healthy adults. HC002 is an investigational, orally bioavailable small molecule under development by Holoclara that is based on molecules identified in worms.

“Initiating our Phase 1 clinical trial for HC002 is more than a milestone for Holoclara — it is a first in humans and in medicine that could bring significant relief and benefit to the millions of patients suffering from chronic inflammatory diseases,” said Andrea Choe, M.D., Ph.D., co-founder and Chief Executive Officer of Holoclara. “We are proud to bring a completely new type of medicine into the clinic — that harnesses molecules from worms, our natural partners who have co-evolved with humans and protected us from disease over millennia — and look forward to further progress on HC002 and our broader portfolio.”

About the Phase 1 Trial

Holoclara has completed its first Good Manufacturing Practice (GMP) batch of HC002, which will be used in the Phase 1 clinical trial. The randomized, double-blind, placebo-controlled, first-in-human dose escalation study will recruit healthy adult volunteers. HC002 will be administered orally.

The trial is being conducted in Australia, where Holoclara has partnered with global clinical research organization Novotech and CMAX Clinical Research (CMAX), a leading clinical trial operator for early phase studies located in Adelaide, South Australia. CMAX will recruit and enroll participants and perform the study. Results are expected in 2025.

“The CMAX team are thrilled to partner with Holoclara to initiate the first-ever trials on the company’s breakthrough class of worm-derived medicines,” said Jane Kelly, Chief Executive Officer of CMAX Clinical Research. “As one of Australia’s largest and most experienced clinical trial operators, CMAX is ideally suited to run early phase and first-in-human studies together with innovative biotechnology companies from around the world.”

"Holoclara has brought into the clinic a totally novel, first-in-class technology that leverages extraordinary therapeutic attributes from worms and can make a global-reaching impact on how we treat inflammatory diseases," said Thomas Polasek, M.D., Ph.D., Associate Medical Director at CMAX and principal investigator for the study. “We are proud to host Holoclara's first-in-human trial for HC002, which is a significant step towards putting breakthrough worm-derived therapies into the hands of patients around the world."

Full details of the study are available at ClinicalTrials.gov.

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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