Expectations rise for HanAll Biopharma's Parkinson's drug HL192

HanAll Biopharma has secured positive results from a phase 1 clinical trial of HL192 (ATH-399 in NurrOn Pharmaceuticals’ code name), a drug for Parkinson's disease being jointly developed with Daewoong Pharmaceutical and NurrOn Pharmaceuticals.

HL192 (ATH-399A), a candidate for treating neurodegenerative diseases discovered by NurrOn Pharmaceuticals, is expected to treat both symptoms and pathogenesis by activating Nurr1 to increase dopamine levels in the body and prevent nerve cell death.

HanAll Biopharma and Daewoong Pharmaceutical partnered as early investors in NurrOn Pharmaceuticals in 2022. They expanded their open collaboration in 2023 by entering into joint development to develop a treatment for Parkinson's disease. NurrOn Pharmaceuticals also received a $1.7 million research grant from the Michael J. Fox Foundation (MJFF) to conduct the phase 1 study.

The trial was conducted in 76 healthy adults and included a single ascending dose (SAD) and multiple ascending doses (MAD) of HL192 (ATH-399A). Participants received HL192 (ATH-399A) once daily in the SAD study and once daily for 12 days in the MAD study to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of HL192 (ATH-399A) compared to placebo.

Results showed that HL192 (ATH-399A) was well tolerated at all five doses, and pharmacodynamic analyses demonstrated that HL192 (ATH-399A) was well tolerated and safe compared to placebo when administered orally once daily. There was an equivalent rate of treatment-emergent adverse events (TEAEs) between patients receiving HL192 (ATH-399A) and placebo, and no adverse or serious adverse events were observed with dose escalation.

All doses used in the study were below the prespecified no-observed-adverse-event level (NOAEL), demonstrating excellent safety and tolerability.

Based on these results, the three companies plan to enter clinical trials to evaluate the efficacy and safety of HL192 (ATH-399A) in patients with Parkinson's disease.

“We are pleased to have completed another important step in developing a fundamental treatment for Parkinson's disease,” HanAll Biopharma CEO Jeong Seung-won said. “We expect the results of this phase 1 study to provide hope to Parkinson's patients and their caregivers worldwide.”

NurrOn Pharmaceuticals CEO Kim Deog-joong said, “Having confirmed the safety of HL192 (ATH-399A) in healthy adults in phase 1, we look forward to moving forward with clinical trials in patients as soon as possible,”