Halia Therapeutics Completes Recruitment for Phase 2a Trial of HT-6184 in Myelodysplastic Syndrome
Halia Therapeutics Clinically Advances HT-6184 for Myelodysplastic Syndrome
Halia Therapeutics, a leading clinical-stage biopharmaceutical company, has announced the conclusion of patient recruitment for their pivotal Phase 2a clinical trial assessing HT-6184, also known as Ofirnoflast, in lower-risk myelodysplastic syndrome (MDS) patients who are either refractory, intolerant, or not eligible for erythropoiesis-stimulating agents (ESAs).
The Phase 2a study, registered under CTRI/2023/11/059758, aims to evaluate the efficacy, safety, and biomarker responses associated with HT-6184. This innovative treatment modulates the Nek7 protein to disrupt interactions with NLRP3 proteins, effectively inhibiting the formation of the NLRP3 inflammasome. By disrupting this crucial inflammatory pathway, HT-6184 targets the challenges posed by bone marrow dysfunction in patients with MDS.
The study is structured in two stages, having successfully recruited 18 evaluable patients in Stage 1, followed by an additional 15 participants completing recruitment in Stage 2. Dr. David Bearss, CEO of Halia Therapeutics, emphasized the significance of achieving this recruitment milestone: "This step is pivotal as we continue to validate our action mechanism focused on innate immune dysregulation. The ongoing study provides critical proof-of-concept data supporting HT-6184's therapeutic potential in reducing clonal inflammation and improving hematological outcomes for symptomatic anemia patients."
The trial involves a treatment duration of 16 weeks, followed by a continuation phase based on patient responses. Responders can continue their treatment, while non-responders exhibiting over a 30% reduction in variant allele frequency (VAF) may receive up to an additional 16 weeks of treatment, either as monotherapy or in combination with previous ESA therapy. The main objectives include improving hematological efficacy, suppressing clonality, reducing VAF, ensuring patient safety and tolerability, monitoring changes in inflammasome-related biomarkers, and evaluating quality of life through patient-reported outcome assessments.
An interim analysis was conducted following Stage 1, and initial results from the full study are projected to be released later this year.
About Halia Therapeutics
Halia Therapeutics is at the forefront of redefining treatment paradigms by targeting the innate immune system and leveraging genetic resilience. Their innovative therapies are based on groundbreaking research identifying protective mutations in individuals genetically predisposed to severe diseases. The aim is to restore immune balance in inflammatory and neurodegenerative conditions.
The company’s pipeline includes:
For further details on HT-6184, HT-4253, or ongoing clinical trials, please visit www.haliatx.com.
Media Contact
Taylor Avei
Director of Business Development
Halia Therapeutics
Email
Halia Therapeutics, a leading clinical-stage biopharmaceutical company, has announced the conclusion of patient recruitment for their pivotal Phase 2a clinical trial assessing HT-6184, also known as Ofirnoflast, in lower-risk myelodysplastic syndrome (MDS) patients who are either refractory, intolerant, or not eligible for erythropoiesis-stimulating agents (ESAs).
The Phase 2a study, registered under CTRI/2023/11/059758, aims to evaluate the efficacy, safety, and biomarker responses associated with HT-6184. This innovative treatment modulates the Nek7 protein to disrupt interactions with NLRP3 proteins, effectively inhibiting the formation of the NLRP3 inflammasome. By disrupting this crucial inflammatory pathway, HT-6184 targets the challenges posed by bone marrow dysfunction in patients with MDS.
The study is structured in two stages, having successfully recruited 18 evaluable patients in Stage 1, followed by an additional 15 participants completing recruitment in Stage 2. Dr. David Bearss, CEO of Halia Therapeutics, emphasized the significance of achieving this recruitment milestone: "This step is pivotal as we continue to validate our action mechanism focused on innate immune dysregulation. The ongoing study provides critical proof-of-concept data supporting HT-6184's therapeutic potential in reducing clonal inflammation and improving hematological outcomes for symptomatic anemia patients."
The trial involves a treatment duration of 16 weeks, followed by a continuation phase based on patient responses. Responders can continue their treatment, while non-responders exhibiting over a 30% reduction in variant allele frequency (VAF) may receive up to an additional 16 weeks of treatment, either as monotherapy or in combination with previous ESA therapy. The main objectives include improving hematological efficacy, suppressing clonality, reducing VAF, ensuring patient safety and tolerability, monitoring changes in inflammasome-related biomarkers, and evaluating quality of life through patient-reported outcome assessments.
An interim analysis was conducted following Stage 1, and initial results from the full study are projected to be released later this year.
About Halia Therapeutics
Halia Therapeutics is at the forefront of redefining treatment paradigms by targeting the innate immune system and leveraging genetic resilience. Their innovative therapies are based on groundbreaking research identifying protective mutations in individuals genetically predisposed to severe diseases. The aim is to restore immune balance in inflammatory and neurodegenerative conditions.
The company’s pipeline includes:
- - HT-6184, currently in Phase 2a trials for MDS
- - HT-6184 in combination with semaglutide, with a planned Phase 2a trial for obesity and Type 2 diabetes (T2D) scheduled to commence in Q3 2025.
- - HT-4253, a candidate targeting neuroinflammation, which is currently undergoing a Phase 1 clinical trial and is expected to conclude by Q3 2025.
For further details on HT-6184, HT-4253, or ongoing clinical trials, please visit www.haliatx.com.
Media Contact
Taylor Avei
Director of Business Development
Halia Therapeutics
Topics Health）
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