First Healthy Volunteer Dosed with HT-4253, a Novel Oral LRRK2 Inhibitor Targeting Neuroinflammation in Alzheimer's Disease

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LEHI, Utah, Oct. 7, 2024. Halia Therapeutics, a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for inflammatory and neurodegenerative diseases, today announced that the first healthy volunteer was dosed in its Phase 1 clinical trial evaluating its LRRK2 inhibitor, HT-4253, for a potential treatment for Alzheimer's Disease.

"Dosing the first subject in the Phase 1 trial of HT-4253 marks a significant step in the fight against neurodegenerative diseases such as Alzheimer's disease," said Dr. David Bearss, CEO of Halia Therapeutics. "We believe that HT-4253 will provide a groundbreaking treatment option for patients who currently have few choices to prevent or delay Alzheimer's onset, as the drug targets the underlying neuroinflammation linked to causing neurocognitive disease."

The Phase 1 clinical trial (ClinicalTrials.gov ID: NCT06537817) is a first-in-human, randomized, placebo-controlled, double-blind study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HT-4253. 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 designed to explore the potential of HT-4253 to inhibit LRRK2. Recent human genetic studies have revealed specific variants of the Rab10 gene protect individuals with the APOE4 genotype—a known risk factor for Alzheimer's disease. These variants inhibit Rab10, a key protein activated by LRRK2, thus reducing neuroinflammation and offering neuroprotection. Halia's LRRK2 inhibitor, HT-4253, mimics these Rab10 variants by blocking LRRK2, which in turn prevents Rab10 activation. This mechanism shows promise for preventing or delaying Alzheimer's onset in APOE4 carriers by replicating the protective effects observed in resilient individuals.

About HT-4253

HT-4253 is an orally administered small molecule tablet with excellent brain penetration. It targets LRRK2, a key mediator of neuroinflammation. Chronic brain inflammation drives several neurodegenerative diseases, including Parkinson's and Alzheimer's. Halia scientists have demonstrated that LRRK2 is crucial in regulating neuroinflammation. By inhibiting LRRK2, HT-4253 could offer a novel approach to treating neurodegenerative diseases with an inflammatory component, potentially altering disease progression.

About Halia Therapeutics, Inc.

Halia Therapeutics is pioneering novel therapeutics to enhance patients' lives affected by chronic inflammatory disorders and neurodegenerative diseases. Our initial programs focus on NEK7 and LRRK2 targets. Our lead candidate, HT-6184—a novel NEK7/NLRP3 inhibitor—has successfully completed a Phase I study (NCT05447546). This study evaluated HT-6184's safety and tolerability when administered as single or multiple oral doses at escalating levels in healthy volunteers. Additionally, we've completed a Phase II trial assessing HT-6184's efficacy on post-procedure diagnostic biomarkers of inflammation and pain (NCT06241742). Currently, we're conducting a Phase II trial to investigate HT-6184's efficacy in treating lower-risk myelodysplastic syndromes (LR-MDS).

Headquartered in Lehi, Utah, Halia Therapeutics is at the forefront of innovative drug development.

SOURCE Halia Therapeutics

Posted : 2024-10-08 06:00

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