HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Initiate First-in-Human Phase 1 Clinical Study of HL192

• 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.

ROCKVILLE, Md. and SEOUL, South Korea, Oct. 12, 2023 /PRNewswire/ -- 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.

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presences in Korea, the USA, Japan, and Indonesia with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for 50 years.

HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF-alpha inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and China for the treatment of dry eye disease. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]).

About Daewoong Pharmaceutical

Established in 1945, Daewoong Pharmaceutical is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on their course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide.

In 2022, Daewoong expanded its global market presence by entering into a license agreement worth USD 923 million, which granted permission for the use of Fexuclue, a medicine licensed for the treatment of gastroesophageal reflux disease, in the Philippines and Ecuador within the first year of its launch. Additionally, Daewoong successfully launched Envlo, the first-ever sodium glucose cotransporter 2 (SGLT2) inhibitor for the treatment of diabetes to be developed in Korea, and signed an export contract worth USD 84.36 million with Brazil and Mexico. For further information on Daewoong Pharmaceutical, please visit our official website.

About NurrOn Pharmaceuticals

NurrOn Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel, targeted therapeutics for the treatment of Parkinson's disease (PD) and other Nurr1-related incurable human disorders.

Through targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance, we aim to develop a paradigm changing PD treatment to improve patients' quality of life. While currently there are only symptomatic treatment options for patients with PD, there have not been any successful therapies to slow or prevent the progression of the disease. We believe that disease-modifying therapies will be achieved through targeting Nurr1, which has generated supportive data as a new druggable PD target. NurrOn was awarded a substantial grant from Michael J. Fox Foundation in support of the Phase 1 clinical trial of ATH-399A/HL192, that initiated in the second half of 2023. For further information on NurrOn Pharmaceuticals, please visit our official website or contact [email protected].  

Disclaimer Statement 

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2023 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. 

SOURCE HanAll Biopharma

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