• HanAll Biopharma and Daewoong Pharmaceutical marked a pivotal step forward in the development of HL192 (ATH-399A) for the potential treatment of Parkinson's Disease in collaboration with NurrOn Pharmaceuticals.
• The Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy participants.
• The companies have also entered a strategic partnership with NurrOn Pharmaceuticals to explore the potential of HL192 in an array of neurodegenerative diseases.

HanAll Biopharma (KRX: 009420. KS), Daewoong Pharmaceutical (KRX: 069620.KS), 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).

PD is primarily caused by the selective degeneration of midbrain dopamine neurons, affecting 1–2% of the global population over the age of sixty-five^[1] and is increasing more than any other neurological disorder globally^[2]. Currently there is no cure for this debilitating disorder and no known treatments that have proven to slow down its progression. The available pharmacological treatments target symptoms and lose their efficacy over time, most with accompanying severe motor side effects such as dyskinesia. Thus, there is an unmet clinical need to develop mechanism-based and/or disease-modifying treatments.

The molecule originated from NurrOn Pharmaceuticals, which was founded by Professor Kwang-Soo Kim, Director of the Molecular Neurobiology Laboratory at Harvard Medical School, and Deog Joong Kim. HL192 is a first-in-class small molecule that focuses on activating Nurr1, a master regulator associated with the development and maintenance of dopaminergic neurons. HL192 improved behavioral deficits in an animal model with PD, demonstrating its potential as a disease-modifying agent.

HanAll Biopharma, in collaboration with Daewoong Pharmaceutical, solidified a co-development partnership with NurrOn Pharmaceuticals to leverage the therapeutic potential of HL192 across various neurodegenerative diseases.

"HanAll, Daewoong, and NurrOn share the common goal of developing transformative treatments for PD. Our collaboration has shown promise, and we will continue to build on this joint effort. Today, we stand at a significant juncture, having achieved the start of our first-in-human trial for HL192. Having reached this key milestone, our next steps involve assessing HL192's broader impact for patients with Parkinson's disease globally as well as for other neurodegenerative conditions," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

"We are pleased to announce that the collaborative efforts between Daewoong and HanAll have achieved their first milestone of HL192. Moving forward, we will strengthen partnership with potential partners to advance science through various collaborative avenues," said Sengho Jeon, CEO of Daewoong Pharmaceutical.

"We are excited to begin the first step in the clinical development of ATH-399A. We look forward to completing the healthy participant study and advancing ATH-399A for a Phase 2 study in PD patients. We are grateful to HanAll and Daewoong for their collaboration and to MJFF for funding the Phase 1 trial of ATH-399A," said Deog Joong Kim, Ph.D., CEO of NurrOn Pharmaceuticals.

NurrOn was awarded a substantial grant from The Michael J. Fox Foundation (MJFF) for Parkinson's Research to support the Phase 1 clinical trial of HL192.

"MJFF is committed to fulfilling the unmet needs of people with Parkinson's disease by funding therapeutic research. The field of research in neurodegenerative disease is advancing rapidly, and the Foundation is pleased to award a grant to NurrOn to develop a treatment aimed at the core biology of Parkinson's," said Katharina Klapper, PhD, Director of Clinical Research, MJFF.

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.