Halia Therapeutics Partners with Southern Star Research to Develop LRRK2 Inhibitor HT-4253 for Neurodegenerative Diseases

Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company based in Lehi, Utah, has announced a strategic collaboration with Southern Star Research Pty Ltd, an Australian contract research organization (CRO). This partnership will initiate a Phase 1 clinical trial for Halia's LRRK2 inhibitor, HT-4253, marking an important step in battling neurodegenerative conditions like Alzheimer's Disease.

Dr. David J Bearss, CEO of Halia Therapeutics, emphasized the significance of this partnership, citing Southern Star Research's clinical expertise and commitment to excellence as key factors. "Partnering with Southern Star Research is a strategic milestone for Halia as we advance HT-4253 into clinical development. Their expertise and unwavering dedication to clinical excellence make them the perfect ally in our mission to develop innovative therapies that target the root causes of neurodegeneration," Bearss stated. He added that the initiation of the Phase 1 trial represents a hopeful stride towards potentially life-changing treatments for patients worldwide.

David Lloyd, Managing Director of Southern Star Research, echoed this enthusiasm, highlighting the importance of the collaboration in their long-term commitment to novel therapeutics for neurodegenerative diseases. "We are excited to collaborate with Halia Therapeutics on the Phase I SAD/MAD study of HT-4253 in healthy volunteers. This partnership represents a significant step in our long-term commitment to advancing novel therapeutics for the treatment of neurodegenerative diseases such as Alzheimer's Disease, an area with an enormous unmet need," Lloyd commented.

The clinical trial is scheduled to begin in the fourth quarter of 2024, with preliminary results anticipated in 2025. Both Halia and Southern Star Research are dedicated to maintaining the highest standards of safety, compliance, and scientific integrity throughout the study, aiming to bring hope to millions affected by neurodegenerative diseases.

The Phase 1 clinical trial, identified as NCT06537817, will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-4253 in healthy volunteers. The study will utilize a single ascending dose (SAD) and multiple ascending dose (MAD) format to explore HT-4253's potential to inhibit LRRK2, an enzyme implicated in neuroinflammatory and neurodegenerative diseases, including Alzheimer's and Parkinson's.

HT-4253 is an orally administered small molecule that penetrates the brain and targets LRRK2, a key mediator of neuroinflammation. Chronic brain inflammation is a contributing factor to several neurodegenerative diseases, including Parkinson's and Alzheimer's. Inhibiting LRRK2 with HT-4253 could represent a novel approach to treating these diseases by altering disease progression.

Halia Therapeutics is dedicated to discovering and developing novel therapeutics for chronic inflammatory disorders and neurodegenerative diseases. Their lead candidate, HT-6184, a NEK7/NLRP3 inhibitor, has completed a Phase I study evaluating its safety and tolerability at escalating dose levels in healthy volunteers. Halia has also initiated two Phase II trials to evaluate HT-6184 for lower-risk myelodysplastic syndromes (LR-MDS) and post-procedure diagnostic biomarkers of inflammation and pain.

Southern Star Research Pty Ltd, based in Australia, is a full-service CRO specializing in clinical trial services for biotechnology and pharmaceutical companies. With a focus on quality and partnership, Southern Star is committed to advancing clinical research and bringing innovative therapies to patients.