HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals have announced the successful completion of a Phase 1 study for HL192 (ATH-399A), a potential disease-modifying therapy for Parkinson's disease. The study, a first-in-human trial, met its primary endpoints of safety and tolerability across five ascending dose groups, marking a significant step forward in addressing this debilitating neurological disorder.
The Phase 1 study included single ascending dose (SAD), multiple ascending dose (MAD), and food effect components. A total of 76 healthy participants were enrolled, with the aim of assessing the safety, tolerability, and pharmacokinetic profile of HL192 (ATH-399A).
Safety and Tolerability
The results indicated that HL192 (ATH-399A) was well-tolerated, with no major safety issues reported among the participants. There were no serious treatment-related adverse events, and the incidence of treatment emergent adverse events (TEAEs) was proportional between the placebo and dosed groups. All tested dose levels were well below the pre-determined NOAEL (no observed adverse effect level) concentrations, further confirming the safety and tolerability of the chosen dose levels.
Pharmacokinetic Profile
The pharmacokinetic (PK) results from the study support a once-a-day dosing regimen for HL192 (ATH-399A), which could enhance patient compliance and convenience in future clinical trials.
Expert Commentary
"We are extremely pleased to announce the completion of the first-in-human study," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "Successfully demonstrating the safety and tolerability in healthy volunteers, including older adults, is a key step in our mission to develop a disease-modifying therapy for Parkinson's disease. These findings bring hope to millions of patients and their families who are affected by this challenging condition."
Deog Joong Kim, PhD., CEO of NurrOn Pharmaceuticals, added, "We are excited to report positive results for our Phase 1 trial, confirming the well-tolerated safety profile of HL192 (ATH-399A) in healthy participants and expect to launch the next clinical trial in people with Parkinson's disease."
Support from The Michael J. Fox Foundation
NurrOn Pharmaceuticals received a $1.7 million grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support the Phase 1 clinical trial of HL192 (ATH-399A), which began in the second half of 2023.
Katharina Klapper, principal of clinical research at MJFF, stated, "The Michael J. Fox Foundation remains steadfast in our commitment to accelerate the development of better treatments for the more than 6 million people living with Parkinson's disease around the world. The successful completion of the study's Phase 1 HL192 (ATH-399A) trial marks a meaningful step forward in advancing today's therapeutic pipeline."
Next Steps
HanAll and Daewoong plan to initiate the next clinical trial in patients with Parkinson's disease in collaboration with NurrOn. This study will further evaluate the safety and efficacy of HL192 (ATH-399A) in the target patient population.
About Parkinson's Disease and HL192 (ATH-399A)
Parkinson's disease is a progressive neurological disorder affecting millions globally. Current treatments primarily address symptoms, highlighting the urgent need for therapies that can modify the disease's progression. HL192 (ATH-399A) represents a promising approach by targeting the underlying mechanisms of Parkinson's disease to provide a more effective and long-lasting treatment.
