Celltaxis Announces Peer-Reviewed Publication of Clinical Data Supporting Its Novel Therapeutic Approach to Lymphedema

Clinical findings published in Scientific Reports demonstrate significant improvements in limb volume, skin thickness, tissue architecture and quality of life following once-daily oral treatment with LTA4H inhibitor

Data provide important independent validation of the Celltaxis approach to targeting the LTA4H/LTB4 inflammatory pathway to promote lymphatic repair.

ATLANTA, Oct. 7, 2026 /PRNewswire/ -- Celltaxis, a clinical-stage biotechnology company dedicated to developing novel therapies for lymphatic diseases, today announced the publication of clinical data in Scientific Reports, a peer-reviewed journal from Nature Portfolio, evaluating the Company's foundational drug product, a selective leukotriene A4 hydrolase (LTA4H) inhibitor, in patients with chronic lymphedema. The findings provide important clinical evidence supporting Celltaxis' novel therapeutic approach designed to address the underlying inflammatory biology that contributes to lymphatic dysfunction.

The paper, titled "Therapeutic selective leukotriene b4 antagonism for human lymphedema" (DOI: 10.1038/s41598-026-67215-4), reports findings from an open-label, prospective clinical study evaluating 12 months of once-daily 100 mg oral treatment with Celltaxis' LTA4H inhibitor, acebilustat, when superimposed on existing, maximized maintenance approaches in patients with chronic Stage II lower-extremity lymphedema. The data demonstrated statistically significant improvements across multiple objective measures of disease, including limb volume, skin thickness, and tissue architecture and extracellular fluid content, as well as significant improvements in quantifiable quality of life instruments, providing support for both the symptom relief and the disease-modifying potential of LTA4H inhibition in chronic lymphedema. The study was conducted at the Stanford Center for Lymphatic and Venous Disorders at Stanford University School of Medicine.

"These published clinical findings represent important independent validation of the therapeutic approach we have been advancing at Celltaxis and provide human evidence supporting a fundamentally different way of treating lymphedema," said Eric Springman, Ph.D., Co-Founder and Chief Scientific Officer of Celltaxis. "By targeting the inflammatory biology that interferes with the body's natural ability to repair damaged lymphatic vessels, we believe we have an opportunity to move beyond managing the consequences of lymphatic dysfunction and begin addressing an underlying driver of disease."

Growing scientific evidence has shown that excessive leukotriene B4 (LTB4) signaling suppresses biological pathways responsible for repairing and regenerating damaged lymphatic vessels, and LTB4 has been established, both clinically and non-clinically, as a key driver of lymphedema. By selectively inhibiting LTA4H, the enzyme responsible for producing LTB4, Celltaxis' technology is designed to reduce pathological inflammatory signaling and restore the body's natural lymphatic repair processes, addressing an underlying driver of lymphatic dysfunction rather than simply managing its symptoms.

Lymphedema is a chronic, progressive inflammatory disease caused by damage to or dysfunction of the lymphatic system. When lymphatic vessels become damaged, tissue fluid drainage is impaired, triggering chronic inflammation that can lead to progressive swelling, tissue remodeling, adipose deposition, fibrosis, reduced mobility, and diminished quality of life. Approximately 10 million Americans and an estimated 250 million people worldwide are living with lymphedema. Despite its prevalence and significant patient burden, there are currently no FDA-approved pharmaceutical therapies for the disease.

"Lymphatic diseases represent one of medicine's largest and most overlooked areas of unmet need, yet there has been remarkably little pharmaceutical innovation for the millions of patients living with these chronic disorders," said Eileen Heffernan, Co-Founder and Chief Executive Officer of Celltaxis. "The publication of these clinical data represents an important milestone for Celltaxis and provides further evidence that the pathogenetic mechanisms that drive lymphatic dysfunction can be therapeutically targeted. We believe this approach has the potential to transform the treatment paradigm for lymphedema patients who today are largely limited to lifelong symptom management."

"For far too long, millions of lymphedema patients have felt overlooked, carrying a heavy burden of chronic pain, disfigurement, and emotional exhaustion with only compression garments to manage their symptoms," said Dr. Stanley G. Rockson, the Allan and Tina Neill Professor of Lymphatic Research and Medicine at Stanford University. "We initially identified heightened LTB4 signaling as a key pathogenetic mechanism in experimental models of lymphedema. The results of this investigation serve to validate the importance of this molecular pathway in human disease. Having identified a pharmacology that effectively normalizes LTB4 signaling, we are increasingly confident we will be able to shift the therapeutic paradigm in lymphedema treatment, approaching it as an active inflammatory condition rather than simply managing symptoms. Moreover, targeting LTB4 potentially offers a path to reverse tissue damage and repair lymphatic function, bringing these patients real therapeutic hope where none has previously existed."

Key findings from the published data include:

• Significant Reduction in Limb Volume: Once-daily oral treatment with the LTA4H inhibitor was associated with an average reduction of approximately one liter in lymphedematous limb volume over 12 months (-1,012.3 mL [95% C.I.: -1457.9 to -565.9], P < 0.0001). Significant reductions were evident as early as three months.
• Measurable Decrease in Skin Thickness: Caliper and ultrasonographic evaluations demonstrated significant reductions in skin thickness, with the most prominent effects observed at the proximal calf (-1.1 mm, P = 0.004) and midthigh (-1.6 mm, P < 0.001).
• Improved Tissue Architecture & Body Composition Analysis: Ultrasonographic analysis and bioimpedance measurements revealed structural changes supporting favorable impact on affected tissue architecture and extracellular fluid accumulation (R₀ 13.8 [95% C.I.: 1.8 to 25.8], P = 0.03).
• Novel AI-Driven Ultrasound Biomarker Pipeline: Ultrasound data provide additional imaging evidence of improved tissue remodeling and disease modification. To quantitatively evaluate cutaneous ultrasound images, researchers deployed a newly developed artificial intelligence pipeline to assess tissue changes as an exploratory biomarker.
• Enhanced Patient Quality of Life: Objective physical improvements were accompanied by patients reported statistically significant improvement on the lymphedema-specific visual analog scale (LymVAS), evident by 3 months and sustained through 12 months (P < 0.001).

About Celltaxis
Celltaxis is a clinical-stage biotechnology company pioneering the development of pharmaceutical therapies targeting lymphatic dysfunction, with the goal of transforming the treatment paradigm for lymphedema, lipedema, and other lymphatic diseases, which affect many millions of patients worldwide. The Company's Phase 2 program is focused on a highly selective leukotriene A4 hydrolase (LTA4H) inhibitor that facilitates lymphatic repair. Celltaxis is advancing a new chemical entity prodrug of this small molecule designed to improve the drug's pharmacokinetics and impart additional patient benefits. For more information, visit www.celltaxis.com.

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SOURCE Celltaxis