HT-4253 / Halia Therap - LARVOL DELTA

Halia Therapeutics Completes First-in-Human Phase 1 Study of HT-4253, a Novel LRRK2 Inhibitor Targeting Neuroinflammation (PRNewswire) - "Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company redefining treatment paradigms through inflammation-targeted and resilience-driven therapies, today announced the successful completion of its first-in-human Phase 1 clinical trial evaluating HT-4253 in healthy adult volunteers...The randomized, double-blind, placebo-controlled single- and multiple-ascending-dose (SAD/MAD) trial (ClinicalTrials.gov Identifier: NCT06537817) was conducted at CMAX Clinical Research in Adelaide, Australia...The primary objectives of the trial were safety and tolerability, with secondary endpoints assessing pharmacokinetics (PK) and pharmacodynamics (PD. HT-4253 was generally well tolerated across all dose levels, with no serious adverse events reported. A comprehensive Clinical Study Report (CSR) is anticipated in Q4 2025."

Trial completion • Trial status • CNS Disorders

Study to Evaluate HT-4253 in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Halia Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

Halia Therapeutics to Attend Global Health Exhibition 2024 (PRNewswire) - "Halia Therapeutics will host an exhibition booth to showcase its efforts in targeting two indications, Alzheimer's disease and obesity. Halia's candidate HT-4253 is a LRRK2 inhibitor administered orally with excellent brain penetration. LRRK2 is a key modulator of neuroinflammation, which plays a critical role in neurodegenerative diseases. HT-6184 is a first-in-class, selective and orally bioavailable inhibitor of the NEK7/NLRP3 inflammasome. HT-6184 is being tested in combination with semaglutide to target inflammation, which has been linked to obesity-related metabolic dysfunction."

Clinical • Alzheimer's Disease • CNS Disorders • Inflammation • Obesity

Halia Therapeutics Announces First Healthy Volunteer Dosed with HT-4253, a Novel Oral LRRK2 Inhibitor Targeting Neuroinflammation in Alzheimer's Disease (PRNewswire) - "Halia Therapeutics...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....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."

Trial status • Alzheimer's Disease

Study to Evaluate HT-4253 in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Halia Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Halia Therapeutics Joins Forces with Southern Star Research Pty Ltd to Advance Clinical Development of Novel LRRK2 Inhibitor, HT-4253 for Neurodegenerative Diseases (PRNewswire) - "Halia Therapeutics, Inc...today announced a pivotal strategic collaboration with Southern Star Research Pty Ltd...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...The trial is set to commence in Q4 2024, with preliminary results expected in 2025."

P1 data • Trial status • Alzheimer's Disease • CNS Disorders

Study to Evaluate HT-4253 in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Halia Therapeutics, Inc.

New P1 trial