Bersiporocin hydrochloride

SEOUL, South Korea, Jan. 29, 2024 /PRNewswire/ -- Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received 'Orphan Drug Designation (ODD)' from the European Medicines Agency (EMA), adding to its earlier designation by the U.S. FDA for both IPF and systemic sclerosis. Continue Reading Daewoong Pharmaceutical's Bersiporocin Receives ‘Orphan Drug Designation’ in Europe to Treat Idiopathic Pulmonary Fibrosis The EMA's recognition highlights Bersiporocin's potential to meet critical needs in rare diseases, targeting conditions affecting fewer than 5 in 10,000 individuals in the EU. The designation offers several benefits, including guidance on clinical trials, reduced authorization fees, and 10-year market exclusivity upon approval. IPF is characterized by abnormal collagen accumulation in the lungs, reducing lung function. With a global incidence rate of about 13 cases per 100,000 people and a 5-year survival rate of only 40%, there's a pressing need for more effective and safer treatments. Bersiporocin's mechanism involves inhibiting PRS (Prolyl-tRNA Synthetase), thus targeting the excess collagen production that leads to fibrosis. The drug's efficacy was demonstrated in a study published by the European Molecular Biology Organization (EMBO). In addition to orphan drug designations, Bersiporocin has been granted fast track designation by the FDA. It also has been recognized in the 'Clinical Development Support' program by the Korea Drug Development Fund (KDDF). Bersiporocin has successfully completed phase 1 clinical trials in Korea and Australia, establishing its safety and pharmacokinetic properties in 162 healthy subjects. Multinational phase 2 clinical trials are currently in progress in Korea and the U.S. Seng-ho Jeon, CEO of Daewoong Pharmaceutical, stated, "With Bersiporocin's global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease." Forward-Looking Statements This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials. Photo - Logo -

ROCKVILLE, Md., Dec. 20, 2023 /PRNewswire/ -- HanAll Biopharma (KRX: 009420.KS), Daewoong Pharmaceutical (KRX: 069620.KS), and NurrOn Pharmaceuticals announced their participation in the 7th Annual Sachs Associates Neuroscience Innovation Forum. The event is scheduled to take place on January 7th, 2024, at the historic Marines' Memorial Club in San Francisco, California. The forum immediately precedes the JP Morgan Healthcare Conference, beginning January 8th. The collaborative efforts of HanAll, Daewoong, and NurrOn will be featured in a dedicated presentation highlighting the progress and potential of their ongoing Nurr1-focused Parkinson's Disease Program, currently in Phase I. The forum, renowned for bringing together thought leaders, researchers, and industry experts in the field of neuroscience, provides an ideal platform for HanAll and Nurron to share insights, innovations, and future directions. "We are excited to discuss our joint efforts with Daewoong and NurrOn at the Sachs Neuroscience Innovation Forum, a premier event in the neuroscience community. This collaboration represents a significant step forward in our commitment to advancing therapies with the potential to treat Parkinson's disease as well as to contribute to the evolution of neuroscience research," said Dr. Almira Chabi, Chief Medical Officer and Chief Development Officer at HanAll, who is presenting and also participating as a panelist at the forum. "We eagerly anticipate engaging with thought leaders and industry experts, sharing insights into the clinical development of ATH-399A, our innovative Nurr1 activator that may have the potential to capture both acute beneficial effects and long-term disease modification in Parkinson's disease," said Deog Joong Kim, Ph.D., CEO of NurrOn Pharmaceuticals. In addition to participating at the Neuroscience Innovation Forum, HanAll will also be attending the 42nd Annual J.P. Morgan Healthcare Conference from January 8th to 11th, 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 the areas of 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 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 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 naraesong@daewoong.co.kr. 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 info@nurronpharma.com. 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