LEHI, Utah — November 10, 2025 — Leads & Copy — Halia Therapeutics will present clinical and preclinical data on ofirnoflast (HT-6184), a novel allosteric NEK7 inhibitor, at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, December 6-9, 2025, in Orlando, Florida.
The data includes six poster presentations and one oral presentation, showcasing ofirnoflast’s potential across multiple hematologic conditions, such as myelodysplastic syndrome, hemolytic anemias, and inflammatory conditions. Ofirnoflast is designed to block the formation and promote disassembly of the NLRP3 inflammasome complex by selectively targeting NEK7, an essential component for inflammasome assembly.
Clinical data from an ongoing study indicates that ofirnoflast demonstrates robust and sustained hematologic responses in patients with IPSS-R very low, low, or intermediate risk myelodysplastic syndrome (MDS) and symptomatic anemia. Additional clinical findings suggest that ofirnoflast reduces oxidized mitochondrial DNA levels, IL-8, and other pro-inflammatory cytokines in patients with low-risk MDS and symptomatic anemia. The research suggests that ofirnoflast rewires transcriptional programs in myeloid neoplasms, offering insights into its therapeutic efficacy across multiple hematologic malignancies.
Preclinical studies show that ofirnoflast can suppress heme-induced inflammation, representing a novel therapeutic strategy for hemolytic anemias. Further research reveals that targeting NLRP3 with ofirnoflast, alone or with semaglutide, can ameliorate inflammatory anemia associated with obesity-induced inflammation in rodent models. Collaborative research also highlights the therapeutic potential of targeting pathogenic S100A8/9 alarmins to restore hematopoiesis in models of myelodysplasia and leukemia.
According to Halia Therapeutics CEO David Bearss, the data presented at ASH 2025 marks a significant milestone for the company and patients with myelodysplastic syndrome and other inflammatory hematologic conditions who have limited treatment options. Bearss stated that ofirnoflast’s mechanism offers a different approach to treating these conditions. The CEO also noted that the observed hematologic responses and the favorable safety profile reinforce their commitment to advancing the therapy.
The ASH presentations include:
- Ofirnoflast, a Novel Inflammasome Inhibitor, Rewires Transcriptional Programs and Shows Clinical and Preclinical Efficacy and Myeloid Neoplasms (Saturday, December 6, 2025; 4:00 P.M. – 5:30 P.M. EST)
- Ofirnoflast Suppresses Heme-induced Inflammation, Representing a Novel Therapeutic Strategy for Hemolytic Anemias (Saturday, December 6, 2025; 5:30 P.M. – 7:30 P.M. EST)
- Targeting NLRP3 with Ofirnoflast, Alone or in Combination with Semaglutide, Ameliorates Inflammatory Anemia Associated with Obesity-Induced Inflammation in Rodent Models (Saturday, December 6, 2025; 5:30 P.M. – 7:30 P.M. EST)
- Ofirnoflast The Novel Allosteric NEK7 Inhibitor Ofirnoflast (HT-6184) Suppresses IL-8 and Other Pro-Inflammatory Cytokines in Patients with Low-Risk Myelodysplastic Syndrome and Symptomatic Anemia (Saturday, December 6, 2025; 5:30 P.M. – 7:30 P.M. EST)
- The Novel Allosteric NEK7 Inhibitor Ofirnoflast (HT-6184) Reduces Oxidized Mitochondrial DNA in Patients with Low-Risk Myelodysplastic Syndrome (Saturday, December 6, 2025; 5:30 P.M. – 7:30 P.M. EST)
- The Novel Allosteric NEK7 Inhibitor Ofirnoflast (HT-6184) Demonstrates Robust and Sustained Hematologic Response in Subjects with IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia (Monday, December 8, 2025; 6:00 P.M. – 8:00 P.M. EST)
- Monoclonal Antibodies Against Pathogenic S100A8/9 Alarmins can Restore Hematopoiesis and Result in Immunomodulation in Myelodysplasia and Leukemia Models (Monday, December 8, 2025; 6:00 P.M. – 8:00 P.M. EST)
Halia Therapeutics is focused on developing first-in-class inflammasome inhibitors for inflammatory diseases and hematologic malignancies. The company’s lead program, ofirnoflast, represents a breakthrough approach to treating conditions where the NLRP3 inflammasome drives disease pathology.
Contact: Taylor Avei, Director of Business Development, Halia Therapeutics, info@haliatx.com, +1 (385) 355-4315; Leigh Salvo, New Street Investor Relations, leigh@newstreetir.com
Source: Halia Therapeutics
