Halia Therapeutics Joins Forces with Southern Star Research Pty Ltd to Advance Clinical Development of Novel LRRK2 Inhibitor, HT-4253 for Neurodegenerative Diseases

LEHI, Utah , Sept. 3, 2024 /PRNewswire/ -- Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for inflammatory and neurodegenerative diseases, today announced a pivotal strategic collaboration with Southern Star Research Pty Ltd, a leading Australian contract research organization (CRO). This partnership marks the initiation of a Phase 1 clinical trial for Halia's pioneering LRRK2 inhibitor, HT-4253, signaling a significant leap in the fight against debilitating neurodegenerative conditions such as Alzheimer's Disease.

"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," said Dr. David J Bearss, CEO at Halia Therapeutics. "The initiation of this Phase 1 trial is not just a step forward for Halia but a hopeful stride towards potentially life-changing treatments for patients worldwide."

David Lloyd, Managing Director of Southern Star Research, expressed enthusiasm for the collaboration, stating: "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. Our team is dedicated to supporting the development of pioneering treatments such as HT-4253, and we look forward to contributing to the success of this important clinical trial and many more in the future."

The trial is set to commence in Q4 2024, with preliminary results expected in 2025. Halia and Southern Star Research are committed to upholding the highest standards of safety, compliance, and scientific integrity throughout the study, with the combined mission to bring hope to the millions affected by neurodegenerative diseases.

About HT-4253 Clinical Trial

The Phase 1 clinical trial (NCT06537817) will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-4253 in healthy volunteers. This study will employ a single ascending dose (SAD) and multiple ascending dose (MAD) format, designed to explore the potential of HT-4253 to inhibit LRRK2—a critical enzyme implicated in the pathogenesis of neuroinflammatory and neurodegenerative diseases, including Alzheimer's Disease and Parkinson's Disease.

About HT-4253
HT-4253 is an orally administered small molecule with excellent brain penetration that targets a mediator of neuroinflammation called LRRK2. Chronic inflammation in the brain is a driver of several neurodegenerative diseases, such as Parkinson's disease and Alzheimer's disease. Halia scientists have shown that LRRK2 is an essential regulator of neuroinflammation. LRRK2 inhibition by HT-4253 could represent a new way to treat neurodegenerative diseases with an inflammation component by changing how the disease progresses.

About Halia Therapeutics, Inc.
Halia Therapeutics is discovering and developing a pipeline of novel therapeutics to improve patients' lives with chronic inflammatory disorders and neurodegenerative diseases, with its initial programs targeting NEK7 and LRRK2. Halia's lead candidate, HT-6184, a novel NEK7/NLRP3 inhibitor, has completed a Phase I study (NCT05447546) evaluating the safety and tolerability of HT-6184 when administered as single or multiple oral doses at escalating dose levels in healthy volunteer subjects. Halia has also initiated 2 Phase II trials to evaluate the efficacy of HT-6184 for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) and on post-procedure diagnostic biomarkers of inflammation and pain (NCT06241742).

The company's headquarters are in Lehi, Utah. For more information, visit www.haliatx.com or follow us on LinkedIn and Twitter (X).

About Southern Star Research Pty Ltd

Southern Star Research Pty Ltd is an Australian full-service CRO specializing in providing clinical trial services for biotechnology and pharmaceutical companies. With a strong focus on quality and partnership, Southern Star is dedicated to advancing clinical research and helping bring innovative therapies to patients.

Company Contact

Halia Therapeutics
[email protected]
+1.385.355.4315

Media Contact:
Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
+1 (646) 942-5604
[email protected] 

SOURCE Halia Therapeutics