ATH-399A / NurrOn Pharma, Daewoong Pharma - LARVOL DELTA

HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Announce Successful Completion of a First-in-Human Study for Potential Disease-Modifying Therapy for Parkinson's Disease (PRNewswire) - "HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals successfully completed their Phase 1 study of HL192 (ATH-399A), which is being developed as a disease-modifying therapy for Parkinson's disease. The study met its primary endpoints of safety and tolerability in 5 different ascending dose groups, demonstrating significant progress in the treatment of this debilitating neurological disorder. This first-in-human study included single ascending dose (SAD), multiple ascending dose (MAD), and food effect components."

Trial completion • CNS Disorders • Parkinson's Disease

[NewsPim Lassiro] HanAll Biopharma to release Phase 1 results of Parkinson's disease treatment this month… 'Results analysis in progress' [Google translation] (Newspim) - "According to industry sources on the 14th, HanAll Biopharma completed phase 1 clinical trials for its Parkinson's disease treatment 'HL192' in the second quarter...With significant results from Phase 1 known to have been obtained, it is expected that a clinical plan will be established with the goal of entering Phase 2 within the next year. Depending on the clinical results that will be conducted in the future, it is also expected that indications may be expanded to other diseases besides Parkinson's disease. "

New P2 trial • CNS Disorders • Parkinson's Disease

HanAll Biopharma Reports Q3 2024 Financial Results and Provides Business Update (PRNewswire) - "The Phase 1 study of HL192, being developed in collaboration with NurrOn Pharmaceuticals, HanAll Biopharma, and Daewoong Pharmaceutical, has completed dosing with the results expected in November 2024."

P1 data • CNS Disorders • Parkinson's Disease

Molecule for treatment of Parkinson's clears Phase I of human trials (Daijiworld) - "A molecule developed in India by Professor D.S. Rawat and his team for the treatment of Parkinson's disease has cleared Phase I of human clinical trials...The Phase-1 study is designed to assess the safety, tolerability, pharmacokinetics, and food effect of ATH399A when orally administered to healthy participants aged 18 to 80 years. The study encompasses both a single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The initial results from the Phase 1 clinical trial have now been made available and it has cleared the Phase I trials, making it a perfect molecule to treat Parkinson's disease. Next year the Phase II trials will begin where the Parkinson's disease patient will be treated with this molecule."

New P2 trial • P1 data • CNS Disorders • Parkinson's Disease

A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: HanAll BioPharma Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: HanAll BioPharma Co., Ltd.

New P1 trial

HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Initiate First-in-Human Phase 1 Clinical Study of HL192 (PRNewswire) - "HanAll Biopharma...Daewoong Pharmaceutical...and NurrOn Pharmaceuticals marked a major milestone by dosing the first human healthy participant in their Phase 1 clinical trial, assessing HL192 (NurrOn designation code: ATH-399A) which is being developed for the treatment of Parkinson's disease (PD)....The Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and food effect of HL192 when orally administered to healthy participants aged 18 to 80 years. The study will encompass both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The initial results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024."

Trial status • CNS Disorders • Parkinson's Disease

HanAll Biopharma and Daewoong Pharmaceutical Enter into Co-Development Agreement with NurrOn Pharmaceuticals to Develop Therapy for Parkinson’s Disease (PRNewswire) - "HanAll Biopharma Co., Ltd...and Daewoong Pharmaceutical Co., Ltd...announced that they have entered into a co-development agreement with NurrOn Pharmaceuticals Inc., a Boston-based preclinical-stage biopharma. NurrOn is focused on the discovering and developing novel therapies for people with neurodegenerative diseases including Parkinson's disease (PD) by targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance....Under the agreement, the companies will combine their expertise and resources in developing NurrOn's ATH-399A as well as other compounds targeting Nurr1 for the treatment of neurodegenerative disorders....In addition to proceeding towards a Phase 1 trial of its Parkinson's therapy candidate ATH-399A, the partners will continue to explore the potential of ATH-399A in other neurodegenerative diseases."

Licensing / partnership • CNS Disorders • Parkinson's Disease