Halia Therapeutics Unveils Promising Ofirnoflast Phase 2 Results in MDS and Appoints New Chief Medical Officer
Halia Therapeutics Unveils Promising Ofirnoflast Phase 2 Results in MDS and Appoints New Chief Medical Officer
Halia Therapeutics, Inc. has made headlines with its significant findings from the final Phase 2 trials of its innovative drug, Ofirnoflast (HT-6184), intended for patients battling lower-risk myelodysplastic syndrome (LR-MDS). During the upcoming European Hematology Association (EHA) 2026 Hybrid Congress to be held in Stockholm, Sweden, from June 11 to 14, the company is set to share these breakthrough results which show a 67% rate of hematological improvement.
Halia is a clinical-stage biopharmaceutical firm that has been working diligently on breaking new ground with therapies that specifically target the NLRP3 inflammasome, a potent contributor to various inflammatory conditions including lower-risk MDS. This novel class of treatment aims to address significant medical needs by taking a distinct approach.
Key Findings from Phase 2 Trial
The open-label, single-arm Phase 2 study focused on 37 adults diagnosed with very low- to intermediate-risk MDS, characterized by symptoms like anemia or the requirement for red blood cell transfusions. Most trial participants were either intolerant, refractory to treatment, or deemed ineligible for traditional erythropoiesis-stimulating agents (ESAs). Ofirnoflast was administered orally at a dosage of 2 mg daily, following a regimen of five days on and two days off for a maximum of 32 weeks.
Here are some pivotal outcomes from the accepted abstract set to be presented:
- - A striking 67% of patients experienced hematological improvement, showcasing multilineage activity across various metrics.
- - Among transfusion-dependent patients, 55% achieved transfusion independence lasting eight weeks or more, with 39% maintaining this status for at least sixteen weeks.
- - The median duration for transfusion independence reached an impressive 28.5 weeks.
- - Non-transfusion-dependent patients observed a remarkable 75% rate of hematological improvement (HI-E).
- - While the average hemoglobin rise was measured at 4.5 g/dL, only 27% of patients experienced treatment-related adverse events, with just one classified as moderate in severity.
The encouraging results illustrate Ofirnoflast's potential to revolutionize treatment methods for those with LR-MDS, particularly by providing an efficient and safer alternative for patients with significant unmet medical needs.
Leadership Transition with Han Myint as Chief Medical Officer
In a significant development, Halia Therapeutics also announced the appointment of Dr. Han Myint, MD, FACP, as the new Chief Medical Officer. Dr. Myint comes with over three decades of experience in the realm of hematologic malignancies and drug development across both academic and large-scale pharmaceutical organizations. His role will be crucial as Halia gears up to progress Ofirnoflast toward critical clinical trials and broaden its pipeline efforts focusing on innate immune biology.
Dr. Myint expressed enthusiasm about joining Halia, emphasizing the compelling nature of Ofirnoflast's Phase 2 data and aligning it with Halia's mission to refine treatment options for lower-risk MDS patients. His rich background in myeloid diseases, pivotal trial strategies, and regulatory engagement aligns perfectly with the company's growth trajectory.
Presentation Insights at EHA2026
Details regarding Halia's presentation at EHA2026 are as follows:
- - Title: Ofirnoflast, a First-in-Class NEK7 Inhibitor, Induces Robust Transfusion Independence and Multilineage Hematological Improvement in Lower-Risk Myelodysplastic Syndrome (LR-MDS) Phase 2 Results
- - Abstract Number: S174
- - Session: Oral Session S426 - Myelodysplastic Syndromes – Clinical
- - Presenting Author: Varun Bafna, MD
- - Date and Time: Friday, June 12, 2026, from 17:15 to 18:30 CEST
- - Location: A2-3 Hall at Stockholmsmässan, Stockholm, Sweden, and virtually through the EHA Congress platform.
The future looks promising for Halia Therapeutics as it positions itself to lead in the development of innovative therapies targeting critical blood disorders. The company is on an exciting trajectory, with Ofirnoflast as a cornerstone of its strategy, aimed at meeting the needs of an overlooked patient population while simultaneously expanding its therapeutic portfolio. For more information on Halia Therapeutics and its pipeline, visit Halia Therapeutics' website.
Topics Health）
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