WILMINGTON, Del., April 2, 2026 /PRNewswire/ -- Earendil Labs, an AI-driven biotechnology company advancing next-generation biologics, today announced the first patient has been dosed in a Phase IIa clinical trial of HXN-1001, a half-life extended anti-TL1A antibody, in patients with ulcerative colitis, as well as enrollment completion in the Phase I trial of the antibody in healthy volunteers carried out in Australia. The Phase IIa trial is a randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 in ulcerative colitis patients.
HXN-1001 is a half-life extended, next generation anti-TL1A antibody with great potential for the treatment of patients with inflammatory bowel disease (IBD) including ulcerative colitis and Crohn's disease. In preclinical studies, HXN-1001 has demonstrated more potent efficacies in multiple in vitro assays and animal models than several benchmark products currently under clinical development. Besides the extended in vivo half-life, HXN-1001 is formulated at a high protein concentration for subcutaneous injection. Taken together, HXN-1001 represents a potentially more efficacious and more convenient treatment option for IBD patients.
"In the Phase I study in healthy volunteers, HXN-1001 in single doses up to 1200 mg and multiple doses of 450 mg was well tolerated with a favorable safety profile. The antibody showed a half-life of about 8 weeks when dosed in the projected therapeutic dose range, with low incidence of anti-drug antibody response." Zhenping Zhu, MD, PhD, President & Co-CEO of Earendil Labs, commented, "We are working diligently to advance HXN-1001 clinical programs in a hope to bring a new and efficacious therapeutic option for IBD patients expeditiously."
Jian Peng, PhD, CEO of Earendil Labs, stated, "The progression of HXN-1001 clinical development is a significant step on our pursuit of developing next-generation best-in-class biologic therapeutics in the treatment of patients suffering from IBD. We look forward to working closely with the clinical investigators and the IBD community to advance our development programs globally and to fully realize the great potential of HXN-1001."
About Earendil Labs
Earendil Labs is an AI-driven biotechnology company advancing next-generation biologics for patients with autoimmune diseases, cancer, and other areas of significant unmet medical need. By integrating artificial intelligence across the full R&D lifecycle, Earendil Labs and its affiliate Helixon Therapeutics have been building a scalable engine to systematically generate and advance high-quality therapeutic programs.
The company's AI-native approach enables efficient creation, optimization, and progression of protein-based biologics with the potential to be first-in-class and best-in-class, translating computational innovation into real clinical and patient impact. Through a combination of internal pipeline development and strategic partnerships, Earendil Labs aims to deliver transformative medicines to patients worldwide.
View original content:SOURCE Earendil Labs
