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Yahoo
5 days ago
- Business
- Yahoo
Enrolment concludes in Halia's Phase IIa trial of HT-6184 for MDS
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). 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. Halia 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. "Enrolment concludes in Halia's Phase IIa trial of HT-6184 for MDS" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
6 days ago
- Business
- Associated Press
Halia Therapeutics Completes Enrollment in Phase 2a Clinical Trial of HT-6184 for Myelodysplastic Syndrome (MDS)
LEHI, Utah, June 4, 2025 /PRNewswire/ -- Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering therapies inspired by genetic resilience, today announced the completion of enrollment for its open-label Phase 2a clinical trial evaluating HT-6184 (Ofirnoflast) in patients with lower-risk Myelodysplastic Syndrome (MDS) who are refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents (ESA). The study ( CTRI/2023/11/059758 ) is designed to evaluate the efficacy, safety, and biomarker response of HT-6184, a novel allosteric modulator of NEK7 that disrupts NEK7–NLRP3 protein interaction, thereby preventing the formation of the NLRP3 inflammasome. This mechanism also promotes the disassembly of pre-formed NLRP3 inflammasomes, targeting a key inflammatory pathway implicated in bone marrow dysfunction in myelodysplastic syndromes (MDS). The two-stage study enrolled 18 evaluable patients in Stage 1 and has now completed enrollment of an additional 15 participants in Stage 2. 'Completing enrollment in our Phase 2a MDS study is a major milestone as we continue to validate our mechanism of action targeting innate immune dysregulation,' said Dr. David Bearss, CEO of Halia Therapeutics. 'This study provides important proof-of-concept data to support the therapeutic potential of HT-6184 in reducing clonal inflammation and improving hematologic outcomes for patients with symptomatic anemia.' The trial consists of a 16-week treatment period, followed by a response-based continuation phase. Responders may continue on therapy, while non-responders showing a greater than 30% reduction in variant allele frequency (VAF) clone size may receive up to 16 additional weeks of treatment, either as monotherapy or in combination with prior ESA therapy. Key study objectives include evaluating efficacy through hematological improvement, clonal suppression, and VAF reduction, assessing safety and patient tolerance, monitoring changes in inflammasome-related biomarkers, and measuring quality of life using patient-reported outcome tools. An interim analysis was conducted following Stage 1, and topline results from the complete study are expected later this year. About Halia Therapeutics Halia Therapeutics is redefining treatment paradigms by targeting the innate immune system and harnessing genetic resilience. Founded on breakthrough research identifying protective mutations in individuals genetically predisposed to severe diseases, Halia's therapies aim to restore immune balance in inflammatory and neurodegenerative conditions. The company's pipeline includes: For more information about Ofirnoflast (HT-6184), HT-4253, or ongoing clinical trials, please visit Media Contact Taylor Avei Director of Business Development Halia Therapeutics [email protected] View original content to download multimedia: SOURCE Halia Therapeutics
