HL192 (ATH-399A) was well tolerated with no major safety issues in any of the 76 participants.
No serious treatment related adverse events were reported and such findings were proportional between placebo and dosed groups.
PK results support once a day dosing.
ROCKVILLE, Md. and SEOUL, South Korea, Nov. 25, 2024 /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.
"We are extremely pleased to announce the completion of the first-in-human study," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "Successfully demonstrating the safety and tolerability in healthy volunteers, including older adults, is a key step in our mission to develop a disease-modifying therapy for Parkinson's disease. These findings bring hope to millions of patients and their families who are affected by this challenging condition."
"We are excited to report positive results for our Phase 1 trial, confirming the well-tolerated safety profile of HL192 (ATH-399A) in healthy participants and expect to launch the next clinical trial in people with Parkinson's disease," said Deog Joong Kim, PhD., CEO of NurrOn Pharmaceuticals.
NurrOn was awarded a $1.7 million grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) in support of the Phase 1 clinical trial of HL192 (ATH-399A), that initiated in the second half of 2023.
"The Michael J. Fox Foundation remains steadfast in our commitment to accelerate the development of better treatments for the more than 6 million people living with Parkinson's disease around the world," said Katharina Klapper, principal of clinical research at MJFF. "The successful completion of the study's Phase 1 HL192 (ATH-399A) trial marks a meaningful step forward in advancing today's therapeutic pipeline."
Parkinson's disease is a progressive neurological disorder that affects millions of people worldwide. Current treatments primarily focus on managing symptoms, but there is an urgent need for therapies that can alter the disease's progression. HL192 (ATH-399A) represents a promising approach, targeting the underlying mechanisms of Parkinson's disease to provide a more effective and long-lasting treatment.
The study enrolled 76 healthy participants. Participants in the SAD and food effect arms received HL192 (ATH-399A) once, while participants in the MAD arm received a single dose once a day for twelve days, with careful monitoring and assessment of safety and tolerability. The results demonstrated a favorable safety profile. Key findings include equivalent percentages of treatment emergent adverse events (TEAEs) between those who received treatment compared to those who received placebo, with no clear dose dependent trends. Additionally, all tested dose levels were well below the pre-determined NOAEL (no observed adverse effect level) concentrations, further confirming the safety and tolerability of the chosen dose levels.
HanAll and Daewoong plan to initiate the next clinical trial in people with Parkinson's disease in collaboration with NurrOn. The study will further evaluate the safety of HL192 (ATH-399A). The companies remain dedicated to developing this important asset with the goal to improve patient lives in an area of great unmet need.
About HanAll Biopharma
HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the 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 the therapeutic areas of endocrine, circulatory, and urologic diseases for over 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. One of its lead pipeline assets, 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 generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is planned to begin registrational studies in GD and Rheumatoid Arthritis (RA).
Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 clinical study in the US and is also being evaluated in China for the treatment of dry eye disease.
HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers. 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. Co., Ltd.
Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company's diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities.
Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. Daewoong is dedicated to completing the Phase 2 clinical study of this drug by 2025. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected].
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 HL192 (ATH-399A), 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 2024 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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