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Halia Therapeutics Initiates Phase 2a Trial for HT-6184 in Lower-Risk Myelodysplastic Syndromes

Thursday, December 14, 2023

Halia Therapeutics, a clinical-stage biopharmaceutical company, has initiated Phase 2a clinical trials for its lead candidate, HT-6184, a small molecule medication designed to combat inflammation. The trials aim to assess the drug's effectiveness in treating lower-risk myelodysplastic syndromes (LR-MDS), a group of cancers characterized by abnormal bone marrow cell production.

HT-6184 is a first-in-class inhibitor targeting NLRP3/NEK7 inflammasome, a key driver of inflammatory diseases and various malignancies. The Phase 2a trial involves up to 40 LR-MDS patients across multiple sites in India, focusing on evaluating the drug's safety and activity.

Primary endpoints include measuring hematological improvement rates, transfusion dependency, and changes in hemoglobin levels. Secondary endpoints assess the impact on inflammasome activation biomarkers in MDS and changes in somatic gene mutation clone size. The trial is expected to conclude by Q4 2025.

Dr. Margit M. Janát-Amsbury, Chief Medical Officer of Halia Therapeutics, is optimistic about the trial, highlighting the significant milestone achieved with the dosing of the first patient. Positive Phase I trial results demonstrated the drug's safety, tolerability, and its ability to reduce NLRP3-inflammatory cytokines in healthy volunteers.

NLRP3, an innate immune sensor, is crucial in inflammation-related diseases. Halia's therapeutic approach involves inhibiting the NLRP3 inflammasome formation and promoting its disassembly, preventing the release of pro-inflammatory cytokines. Persistent NLRP3 activation is linked to various conditions, including neurodegenerative disorders like Alzheimer's and Parkinson's disease.

HT-6184 targets the protein NEK7 through an allosteric mechanism, disrupting inflammasome complex formation and promoting disassembly in preclinical models. This innovative approach shows promise in inhibiting the inflammatory response.

Halia Therapeutics is optimistic about HT-6184's potential benefits for MDS patients and those with inflammation-related diseases. The Phase 2a trial marks a crucial step in evaluating the broader applications of targeting the NLRP3 inflammasome in various immunological and inflammatory conditions.



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