Latest news with #HaliaTherapeutics
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
Yahoo
29-05-2025
- Business
- Yahoo
Halia Therapeutics CEO Dr. David Bearss to Deliver Keynote Address at Med Investment Forum 2025 in Abu Dhabi
ABU DHABI, UAE, May 28, 2025 /PRNewswire/ -- Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering therapies that target the innate immune system, announces that CEO Dr. David Bearss will serve as keynote speaker at the Med Investment Forum 2025. The event will take place on May 29, 2025, at the Rotana Beach Hotel in Abu Dhabi, UAE. Dr. Bearss will present: "Pioneering a New Era of Medicine by Unlocking the Body's Power of Genetic Resilience." The keynote will explore how insights from resilient individuals—those who remain disease-free despite genetic risk—are reshaping therapeutic development. Halia's research, grounded in population-scale genomic data, is enabling breakthrough treatments for inflammatory and neurodegenerative diseases. "The key to solving medicine's toughest challenges lies in understanding why certain individuals are protected from disease," said Dr. Bearss. "At Halia, we're using that insight to design therapies that reprogram the body's immune response at the molecular level, ushering in a new era of precision immunology." Advancing Precision Immunology Through Genetic Resilience Halia Therapeutics is redefining how inflammation drives severe medical conditions through cutting-edge science and a robust development pipeline. The company's lead programs include HT-6184, a NEK7 allosteric modulator in clinical trials for myelodysplastic syndromes (MDS) and obesity, and HT-4253, designed to replicate the protective genetic effect of RAB10 loss-of-function in APOE4 homozygotes who show resilience to Alzheimer's disease. The Med Investment Forum, held under the patronage of the UAE Ministry of Health and Prevention in partnership with the World Health Organization (WHO), serves as a premier global platform connecting health ministers, investors, biotech leaders, and healthtech innovators. Halia's keynote participation underscores the innovation and global impact the Forum champions. The event offers an opportunity to discover transformative biotech solutions and connect with investors and decision-makers who are shaping the future of healthcare. Event Details Date: May 29, 2025 Location: Rotana Beach Hotel, Abu Dhabi, UAE Website: About Halia Therapeutics Halia Therapeutics is a clinical-stage biopharmaceutical company developing therapies that modulate the innate immune system to treat inflammation-driven diseases. By uncovering the biology behind genetic resilience, Halia designs breakthrough treatments for neurodegeneration, hematological disorders, and metabolic diseases. Learn more at Media Contact Taylor AveiDirector of Business DevelopmentHalia Therapeuticsinfo@ View original content to download multimedia: SOURCE Halia Therapeutics 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
Globe and Mail
16-04-2025
- Business
- Globe and Mail
NLRP3 Protein Inhibitors Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsigh
"NLRP3 Protein Inhibitors Clinical Trials" NLRP3 protein inhibitors companies are Halia Therapeutics, Ventus Therapeutics, EpicentRx, Zydus Lifesciences Limited, Monte Rosa Therapeutics, Inflammasome Therapeutics, Ventyx Biosciences, Biolexis Therapeutics, Halia Therapeutics, Olatec Therapeutics, Secarna Pharmaceuticals, Novo Nordisk, NodThera, and others. (Albany, USA) DelveInsight's 'NLRP3 Protein Inhibitors Pipeline Insight 2025' report provides comprehensive global coverage of pipeline NLRP3 protein inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NLRP3 protein inhibitors pipeline domain. The potential for NLRP3 inhibitors extends beyond autoimmune and inflammatory diseases. Ongoing research suggests they may also be effective in treating neurodegenerative diseases like Alzheimer's, Parkinson's, and multiple sclerosis, as well as metabolic conditions like gout and non-alcoholic steatohepatitis (NASH). This broad range of applications is driving market interest. The NLRP3 protein inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NLRP3 protein inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NLRP3 protein inhibitors clinical trial landscape. Key Takeaways from the NLRP3 Protein Inhibitors Pipeline Report DelveInsight's NLRP3 protein inhibitors pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline NLRP3 protein inhibitors. Key NLRP3 protein inhibitors companies such as Halia Therapeutics, Ventus Therapeutics, EpicentRx, Zydus Lifesciences Limited, Monte Rosa Therapeutics, Inflammasome Therapeutics, Ventyx Biosciences, Biolexis Therapeutics, Halia Therapeutics, Olatec Therapeutics, Secarna Pharmaceuticals, Novo Nordisk, NodThera, and others are evaluating new NLRP3 protein inhibitors drugs to improve the treatment landscape. Promising pipeline NLRP3 protein inhibitors such as HT6184, VENT 02, Nibrozetone, ZYIL1, MRT-8102, Kamuvudine-9, VTX 3232, NLRP3 inflammasome inhibitor, Dapansutrile, NNC6022-0001, NLRP3 Research Program, NT 0796, and others are under different phases of NLRP3 protein inhibitors clinical trials. In August 2024, Halia Therapeutics and Biolexis Therapeutics announced an ongoing collaboration that successfully identified a novel brain-penetrant small molecule candidate targeting NLRP3-driven neuroinflammation by leveraging Biolexis' MolecuLern™ AI-enabled approach. This milestone represents a significant advancement in developing treatments for neuroinflammatory disorders, including Parkinson's disease and other neurodegenerative conditions. In June 2024, NodThera announced positive data from its Phase Ib/IIa cardiovascular risk study in inflamed obese subjects, evaluating the effects of its oral, brain-penetrant NLRP3 inflammasome inhibitor NT-0796, on inflammatory, cardiovascular and metabolic risk parameters. In May 2024, Novo Nordisk successfully dosed the first participant in a Phase I clinical study for NNC6022-0001 (formerly known as VENT-01) – an oral NLRP3 inhibitor licensed by Novo Nordisk in September 2022. In April 2024, Ventus Therapeutics announced results from its Phase I clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor. The Phase I trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers. In March 2024, Parkinson's UK announced the investment of GBP 2.1 million to support Neumora Therapeutics to carry out preclinical testing of NMRA-NLRP3, a NLRP3 inhibitor with the potential to reduce inflammation and protect brain cells in Parkinson's. NLRP3 Protein Inhibitors Overview NOD-like receptor family pyrin domain-containing 3 (NLRP3) protein is a key component of the innate immune system, playing a crucial role in the activation of the inflammasome. The NLRP3 inflammasome is responsible for the maturation and release of pro-inflammatory cytokines such as IL-1β and IL-18. This process is essential for host defense against pathogens but can lead to chronic inflammation when dysregulated. Overactivation of the NLRP3 inflammasome is implicated in a wide range of diseases, including autoimmune disorders, metabolic syndromes, neurodegenerative diseases, and certain cancers. Thus, targeting NLRP3 with specific inhibitors has become a promising strategy for treating these inflammatory conditions. NLRP3 protein inhibitors work by either directly blocking the NLRP3 protein or interfering with its activation pathway, thereby preventing the assembly of the inflammasome and subsequent cytokine release. These inhibitors offer a novel therapeutic approach by addressing the root cause of inflammation rather than merely managing its symptoms. Several NLRP3 inhibitors are currently under development, with some already in clinical trials for diseases like gout, rheumatoid arthritis, and type 2 diabetes. Their ability to modulate the inflammatory response makes them a potential game-changer in the treatment of chronic inflammatory diseases, offering hope for more effective and targeted therapies. A snapshot of the Pipeline NLRP3 Protein Inhibitors Drugs mentioned in the report: Nibrozetone: EpicentRx ZYIL 1: Zydus Cadila HT6184: Halia Therapeutics VTX 3232: Ventyx Biosciences VENT 02: Ventus Therapeutics NNC6022-0001: Novo Nordisk Kamuvudine-9: Inflammasome Therapeutics MRT-8102: Monte Rosa Therapeutics Learn more about the emerging NLRP3 protein inhibitors @ NLRP3 Protein Inhibitors Medication and FDA approval NLRP3 Protein Inhibitors Therapeutics Assessment The NLRP3 protein inhibitors pipeline report proffers an integral view of the emerging NLRP3 protein inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the NLRP3 Protein Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Infusion, Intradermal, Intramuscular, Intranasal, Intravaginal, Oral, Parenteral, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule Key NLRP3 Protein Inhibitors Companies: Monte Rosa Therapeutics (NASDAQ: GLUE), Ventyx Biosciences (NASDAQ: VTYX), Zydus Lifesciences Limited (BSE: 532321, NSE: ZYDUSLIFE), and Novo Nordisk (NYSE: NVO, OMX: NOVO-B), Halia Therapeutics, Ventus Therapeutics, EpicentRx, Inflammasome Therapeutics, Biolexis Therapeutics, Olatec Therapeutics, Secarna Pharmaceuticals, and NodThera, and others Key NLRP3 Protein Inhibitors Pipeline Therapies: HT6184, VENT 02, Nibrozetone, ZYIL1, MRT-8102, Kamuvudine-9, VTX 3232, NLRP3 inflammasome inhibitor, Dapansutrile, NNC6022-0001, NLRP3 Research Program, NT 0796, and others Dive deep into rich insights for new NLRP3 protein inhibitors, visit @ NLRP3 Protein Inhibitors Therapies and Drugs Table of Contents 1. NLRP3 Protein Inhibitors Pipeline Report Introduction 2. NLRP3 Protein Inhibitors Pipeline Report Executive Summary 3. NLRP3 Protein Inhibitors Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. NLRP3 Protein Inhibitors Clinical Trial Therapeutics 6. NLRP3 Protein Inhibitors Pipeline: Late-Stage Products (Pre-registration) 7. NLRP3 Protein Inhibitors Pipeline: Late-Stage Products (Phase III) 8. NLRP3 Protein Inhibitors Pipeline: Mid-Stage Products (Phase II) 9. NLRP3 Protein Inhibitors Pipeline: Early-Stage Products (Phase I) 10. NLRP3 Protein Inhibitors Pipeline Therapeutics Assessment 11. Inactive Products in the NLRP3 Protein Inhibitors Pipeline 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products in the NLRP3 Protein Inhibitors Pipeline 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
