HanAll Biopharma and Partners Complete Phase 1 Study for Innovative Parkinson's Therapy
Advances in Parkinson's Disease Treatment: Phase 1 Study of HL192 Completion
Introduction
In a significant stride towards improving therapies for Parkinson’s disease, HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals have announced the successful completion of Phase 1 of their clinical study for HL192 (ATH-399A). The results indicate a promising step forward in a field that has long desired a disease-modifying treatment for this debilitating neurological condition.
Study Overview
Conducted with a total of 76 healthy participants, this Phase 1 trial focused on evaluating both the safety and tolerability of HL192 through various dosage methods. Participants were subjected to different ascending dose groups, which included both single and multiple ascending doses, as well as assessments regarding food effects on the drug's efficacy. The rigorous trial design involved monitoring for any adverse effects while providing a comprehensive view of HL192's pharmacokinetics.
Key Findings
Notably, the study demonstrated a favorable safety profile. Data collected indicated that there were no serious adverse events associated with the treatment. The rates of treatment-emergent adverse events (TEAEs) between participants receiving HL192 and the placebo group were comparable, highlighting the drug's tolerability. Moreover, all doses tested were significantly below the established no observed adverse effect level (NOAEL), confirming the drug's safety across different dosage levels.
Dr. Sean Jeong, CEO of HanAll Biopharma, expressed optimism, stating, "We are extremely pleased to announce the completion of the first-in-human study. Successfully demonstrating 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 affected by this challenging condition.”
Next Steps
Following this promising phase, NurrOn Pharmaceuticals has indicated plans to initiate a next stage trial involving participants who actually have Parkinson's disease. NurrOn’s CEO, Dr. Deog Joong Kim, remarked, "We are excited to report positive results for our Phase 1 trial and expect to launch the next clinical trial in people with Parkinson's disease shortly.”
In this pursuit, NurrOn has received notable support, including a $1.7 million grant from The Michael J. Fox Foundation, emphasizing the importance of advancing therapeutic options for the over 6 million Parkinson’s patients worldwide. Katharina Klapper, the Foundation’s clinical research principal, remarked on the essential nature of these developments, stating, "The successful completion of the study marks a significant step forward in improving treatment options for those living with this disease."
The Promise of HL192
Parkinson’s disease is not merely a symptom management condition; it is progressive, with current therapies primarily focused on alleviating symptoms rather than altering the disease’s trajectory. HL192, targeting Nurr1 pathways, aims to tackle the underlying mechanisms contributing to the progression of Parkinson’s disease. Developing this potentially disease-modifying therapy may offer longer-lasting benefits for patients.
Conclusion
The completion of the Phase 1 study marks an encouraging progression in the quest for treatments that may significantly alter Parkinson’s disease's course. Collaboration among HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals symbolizes a united effort toward addressing one of neurology's most pressing challenges. As they plan to move into further clinical trials, the scientific and medical communities anticipate positively transformative developments for Parkinson’s disease patients around the globe.
For more updates on HL192 and the ongoing efforts in Parkinson’s research, stay connected with HanAll Biopharma, Daewoong, and NurrOn Pharmaceuticals in their upcoming studies.