Halia Therapeutics has completed the enrolment in its Phase IIa trial of HT-6184 (Ofirnoflast) in those with lower-risk myelodysplastic syndrome (MDS).
The two-stage trial is designed to test the therapy in individuals who are intolerant of, refractory to, or ineligible for erythropoiesis-stimulating agents (ESA).
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It will assess the safety, biomarker response, and efficacy of this allosteric modulator of NEK7, targeting a key inflammatory pathway associated with bone marrow dysfunction in MDS.
The trial has enrolled 18 subjects in stage I and an additional 15 in stage II. It includes a 16-week treatment duration, with a continuation phase based on patient response followed.
Those who respond might continue therapy, while those who did not, with > 30% reduction in variant allele frequency clone size, could receive further treatment either as a single agent or in conjunction with previous ESA therapy for 16 extra weeks.
The main objectives of the study are to assess efficacy via haematological improvement, VAF reduction, clonal suppression, safety, biomarker changes, quality of life, and patient tolerance.
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By GlobalDataHalia noted that an interim analysis after stage I has been conducted, and topline outcomes are anticipated later in the year.
Halia Therapeutics CEO Dr David Bearss said: “Completing enrolment in our Phase IIa MDS study is a major milestone as we continue to validate our mechanism of action targeting innate immune dysregulation.
“This study provides important proof-of-concept data to support the therapeutic potential of HT-6184 in reducing clonal inflammation and improving haematologic outcomes for patients with symptomatic anaemia.”
Halia focuses on developing therapies that help restore immune balance in neurodegenerative and inflammatory conditions.
Its pipeline also includes HT-6184 plus semaglutide for a planned Phase IIa trial in obesity and Type 2 diabetes, anticipated to start in the third quarter of this year, and HT-4253 for neuroinflammation, currently in a Phase I trial.
The company began the Phase II trial last year to investigate HT-6184 in managing post-procedural inflammatory and pain responses.
