Three Companies Announce First-in-Human Study Success for Parkinson's Therapy

HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals have successfully concluded the Phase 1 clinical trial for HL192 (ATH-399A), a potential disease-modifying treatment for Parkinson’s disease. Conducted to evaluate the safety and tolerability of the drug, the trial involved 76 healthy participants and included single ascending dose (SAD), multiple ascending dose (MAD), and food effect studies. The results demonstrated a favorable safety profile, with no significant safety concerns or serious adverse events reported among the participants. Additionally, the pharmacokinetic data supports a once-daily dosing regimen for this treatment.

The Phase 1 trial achieved its primary goals, indicating that HL192 (ATH-399A) was well-tolerated across all five dose groups. Participants in the SAD and food effect segments were administered the drug once, while those in the MAD segment received a dose daily for 12 days. The trial's findings revealed that the adverse event rates were comparable between the treatment and placebo groups and showed no apparent dose-dependent trends. Importantly, all dose levels tested were below the predetermined NOAEL (no observed adverse effect level) concentrations, confirming the chosen dose levels' safety and tolerability.

"We are thrilled to announce the successful completion of the first-in-human study," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "Proving the safety and tolerability of HL192 (ATH-399A) in healthy volunteers, including older adults, marks a critical milestone in our mission to introduce a disease-modifying therapy for Parkinson's disease. These encouraging results offer hope to millions affected by this challenging condition."

Deog Joong Kim, PhD., CEO of NurrOn Pharmaceuticals, expressed his excitement over the positive outcomes of the Phase 1 trial. "We are eager to advance to the next stage of clinical trials involving patients with Parkinson's disease," he said. "Our aim is to further evaluate the drug’s safety and ultimately provide a much-needed treatment option for those suffering from this progressive neurological disorder."

NurrOn Pharmaceuticals received a $1.7 million grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support the Phase 1 trial that began in the latter half of 2023. "We remain committed to accelerating the development of better treatments for the over 6 million people globally affected by Parkinson's disease," noted Katharina Klapper, principal of clinical research at MJFF. "The completion of the Phase 1 trial of HL192 (ATH-399A) signifies a substantial step forward in enhancing the therapeutic options available."

Parkinson's disease, which progressively affects neurological functions, currently only has treatments addressing symptoms without halting disease progression. HL192 (ATH-399A) aims to change this by targeting the root mechanisms of the disease, potentially offering a more effective and enduring treatment.

With the Phase 1 study concluded, HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals plan to initiate further clinical trials involving patients with Parkinson's disease. These efforts will continue to focus on assessing the long-term safety of HL192 (ATH-399A) and its potential to improve the lives of individuals affected by Parkinson's disease. The companies are dedicated to advancing this promising therapy to meet the significant unmet needs in treating this debilitating condition.