Ocean Biomedical (NASDAQ: OCEA) Will Target Pulmonary Fibrosis Discoveries as Novel Treatments of Hermansky-Pudlak Syndrome
Ocean Biomedical (NASDAQ: OCEA) Will Target Pulmonary Fibrosis Discoveries as Novel Treatments of Hermansky-Pudlak Syndrome
On Hermansky-Pudlak Syndrome (HPS) Awareness Day, Ocean Biomedical announces
a commitment to developing viable treatment options for HPS-1 and HPS-4
开启 赫尔曼斯基-普德拉克 综合症 (HPS) 宣传日,海洋生物医学 宣布
一个 承诺 发展 可行的治疗选择s 适用于 HPS-1 和 HPS-4
Providence, RI, April 06, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today a strong commitment to targeting its pulmonary fibrosis treatment candidate, "OCF-203," as a novel therapeutic for fatal pulmonary fibrotic conditions caused by Hermansky-Pudlak Syndrome (HPS). Discoveries in recent years by Ocean Biomedical's Scientific Co-founder, Dr. Jack A. Elias, and his colleagues at Brown University, have revealed a new target and a new pathway for treating pulmonary tissue damage in Idiopathic Pulmonary Fibrosis (IPF). Experiments have also been performed with genetically modified "pale-ear" mice, which have the same mutations that are seen in patients with Hermansky-Pudlak Syndrome (HPS). These experiments demonstrated that the same small molecule may be effective in treating pulmonary fibrosis conditions in patients with HPS, especially the most deadly forms of that disease, HPS-1 and HPS-4.
罗得岛州普罗维登斯,2023 年 4 月 6 日(GLOBE NEWSWIRE)— 海洋生物医学公司(纳斯达克股票代码:OCEA)今天宣布,坚定承诺将其肺纤维化候选治疗药物 “OCF-203” 作为治疗赫尔曼斯基-普德拉克综合征(HPS)引起的致命肺纤维化疾病的新疗法。海洋生物医学的科学联合创始人杰克·埃利亚斯博士及其在布朗大学的同事近年来的发现揭示了治疗特发性肺纤维化(IPF)肺组织损伤的新靶点和新途径。还对转基因 “淡耳” 小鼠进行了实验,它们的突变与Hermansky-Pudlak综合征(HPS)患者身上的突变相同。这些实验表明,同样的小分子可能有效治疗 HPS 患者的肺纤维化疾病,尤其是该疾病中最致命的形式,即 HPS-1 和 HPS-4。
Ocean Biomedical's novel approach to treating pulmonary fibrosis – a condition with no disease modifying agents currently available – is focused on inhibiting Chitinase 1 (Chit1) with patented "OCF-203." Chit1 is also a critical biomarker in Scleroderma-associated interstitial lung disease (SSc-ILD) and plays a role in bleomycin- and IL-13-induced pulmonary fibrosis. In four pulmonary fibrosis animal models, Ocean Biomedical's OCF-203 has shown an 85% – 90% reduction in collagen accumulation. The results of this antifibrotic (termed molecule X: SMX) in the bleomycin model can be seen in the diagram above. Results also showed efficacy in the pale-ear mouse model of HPS, including impressive reductions in fibrosis. As a result, efforts are now moving towards IND-enabling studies.
Ocean Biomedical治疗肺纤维化的新方法侧重于通过专利 “OCF-203” 抑制几丁质酶1(Chit1)。Chit1 也是硬皮病相关性间质性肺病 (SSC-ILD) 的关键生物标志物,在博来霉素和白介素-13 引起的肺纤维化中起作用。在四个肺纤维化动物模型中,海洋生物医学的 OCF-203 显示了 85% — 胶原蛋白积累减少 90%。 博来霉素模型中这种抗纤维化(称为分子 X:SMX)的结果可以在上图中看到。 R结果 也显示出疗效 在 淡耳鼠标 模型 的 HPS,包括纤维化的显著减少。 结果,现在正在努力 向 Ind-enabl 迈进ing 学习。
Ocean Biomedical's anti-fibrosis platform seeks to address major unmet needs for IPF and HPS, and has shown potential for expanded application into fibrotic diseases in other organs, such as scleroderma, alcoholic liver disease, NASH, and kidney failure (see below). This unique approach has been developed by a research team led by Dr. Jack A. Elias, who is the former Dean of Medicine and Biology at Brown University, and former Chair of Medicine and Chief of Pulmonology and Critical Care Medicine at Yale University and Yale-New Haven Hospital.
Ocean Biomedical的抗纤维化平台旨在解决IPF和HPS尚未得到满足的主要需求,并显示出将应用范围扩大到其他器官的纤维化疾病的潜力,例如硬皮病、酒精性肝病、NASH和肾衰竭(见下文)。这种独特的方法是由杰克·埃利亚斯博士领导的研究小组开发的,杰克·埃利亚斯博士是布朗大学前医学和生物学系主任,耶鲁大学和耶鲁-纽黑文医院前医学系主任兼肺病学和重症监护医学主任。
IPF is a devastating lung condition that currently affects about 100,000 people per year in the United States, and about 15 per 100,000 people worldwide, with a much higher prevalence in males over 50 years old. The median survival rate ranges from 2 – 5 years. Current standard-of-care therapeutics have limited efficacy and significant side effects such that patients choose to forgo drug therapy. There are no therapies currently available that can reverse loss of lung function.
IPF是一种毁灭性的肺部疾病,目前在美国每年影响约10万人,全球每10万人中约有15人受到影响,50岁以上的男性的患病率要高得多。中位存活率介于 2 — 5 年之间。目前的标准护理疗法疗效有限,副作用明显,因此患者选择放弃药物治疗。目前没有可以逆转肺功能丧失的疗法。
Hermansky-Pudlak Syndrome (HPS) is a rare genetic condition that affects about 1 in 750,000 people worldwide, and about 1 in 1800 people in northwest Puerto Rico. In HPS-1 and HPS-4 patients pulmonary fibrosis occurs early in life (30s and 40s) and symptoms are often severe. Patients who have the HPS-1 or HPS-4 variants of the disease often develop terminal lung fibrosis with no therapeutic treatment currently approved.
赫尔曼斯基-普德拉克综合症(HPS)是一种罕见的遗传病,全球约每75万人中就有1人受到影响,在波多黎各西北部,大约每1800人中就有1人受到影响。在 HPS-1 和 HPS-4 患者中,肺纤维化发生在生命早期(30 多岁和 40 多岁),症状通常很严重。患有该疾病 HPS-1 或 HPS-4 变异的患者通常会发展为晚期肺纤维化,目前尚未批准任何治疗方法。
IPF and HPS are both considered "rare diseases" under the Orphan Drug Act, which qualifies them for potential orphan drug designation, and Ocean is moving towards IND filings for OCF-203 with both patient populations in mind.
根据《孤儿药法》,IPF 和 HPS 都被视为 “罕见疾病”,这使他们有资格获得潜在的孤儿药称号,而且 Ocean 正在考虑这两个患者群体的前提下,向 OCF-203 申请 IND。
"My life's work has been focused on caring for patients with pulmonary conditions and it is difficult to see the limited treatment options that are available for many of these diseases. We are working to change that, and we're really excited about the broad therapeutic potential for this unique treatment pathway," commented Dr. Elias.
“我一生的工作重点是照顾肺部疾病患者,很难看出其中许多疾病的治疗选择有限。我们正在努力改变这种状况,我们对这种独特的治疗途径具有广泛的治疗潜力感到非常兴奋,” 埃利亚斯博士评论道。
"This company was founded by physician-researchers to find solutions for large, unmet medical needs and we are pleased with the possibility of extending the anti-fibrosis platform into a broad range of hard-to-treat conditions," said Dr. Chirinjeev Kathuria, Ocean's co-founder and Executive Chairman.
Ocean的联合创始人兼执行董事长Chirinjev Kathuria博士说:“这家公司由医生和研究人员创立,旨在为大量未得到满足的医疗需求寻找解决方案,我们对将抗纤维化平台扩展到各种难以治疗的疾病的可能性感到满意。”
Suren Ajjarapu, a director of Ocean, commented, "This company is pushing to translate discovery research into the clinic for a range of conditions that will provide global health solutions, and pulmonary fibrosis has potential to have positive returns for patients and our shareholders."
Ocean董事苏伦·阿贾拉普评论说:“这家公司正在努力将发现研究转化为针对一系列疾病的临床研究,这将提供全球健康解决方案,肺纤维化有可能为患者和我们的股东带来积极的回报。”
"We are pleased to see the strong results being generated in our anti-fibrosis platform, and we are proud to be moving them forward, especially for patients with conditions like HPS that do not currently have effective treatment options," said Elizabeth Ng, CEO of Ocean Biomedical.
Ocean Biomedical首席执行官Elizabeth Ng表示:“我们很高兴看到我们的抗纤维化平台取得了强劲的结果,我们很自豪能够推动这些成果,特别是对于像HPS这样目前没有有效治疗选择的患者。”
About Ocean Biomedical
关于海洋生物医学
Ocean Biomedical, Inc. ("Ocean Biomedical" or the "Company") is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world's toughest problems, for the people who need it most.
Ocean Biomedical, Inc.(“海洋生物医学” 或 “公司”)是一家总部位于罗德岛普罗维登斯的生物制药公司,其创新的商业模式可加速研究型大学和医学中心具有科学吸引力的资产的开发和商业化。Ocean Biomedical利用资金和专业知识,将新的候选治疗药物有效地从实验室转移到诊所,再到世界。海洋生物医学目前正在开发五项有前途的发现,这些发现有可能在肺癌、脑癌、肺纤维化以及疟疾的预防和治疗方面取得改变生活的结果。海洋生物医学团队正在努力为最需要的人们解决一些世界上最棘手的问题。
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Forward-Looking Statements
前瞻性陈述
The information included herein and in any oral statements made in connection herewith include "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target," or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include but are not limited to: the expected timing and success of investigational new drug ("IND") filings for our initial product candidates; statements regarding the expected timing of our IND-enabling studies; the frequency and timing of filing additional INDs; expectations regarding the availability and addition of future assets to our pipeline; the advantages of any of our pipeline assets and platforms; the potential benefits of our product candidates; potential commercial opportunities; the timing of key milestones for our programs; the future financial condition, results of operations, business strategy and plans, and objectives of management for future strategy and operations; and statements about industry trends and other companies in the industry. These forward-looking statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company's management, and they are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions.
此处包含的信息以及与此相关的任何口头陈述中包含的信息包括1995年《美国私人证券诉讼改革法》“安全港” 条款所指的 “前瞻性陈述”。前瞻性陈述可以通过使用 “估计”、“计划”、“项目”、“预测”、“打算”、“将”、“期望”、“预期”、“相信”、“寻求”、“目标” 等词语或其他预测或表明未来事件或趋势或不是历史问题陈述的类似表达来识别,尽管并非所有前瞻性陈述都包含此类识别词。这些前瞻性陈述包括但不限于:我们初始候选产品在研新药(“IND”)申请的预期时机和成功率;关于我们支持IND的研究的预期时间的陈述;提交额外IND的频率和时间;对我们未来产品供应和增加资产的预期;我们的任何在研资产和平台的优势;我们的候选产品的潜在收益;潜在的商业机会;关键时机我们的里程碑项目;未来的财务状况、经营业绩、业务战略和计划以及未来战略和运营的管理目标;以及关于行业趋势和该行业其他公司的陈述。这些前瞻性陈述基于各种假设,无论此处是否确定,也基于公司管理层当前的预期,它们不是对实际业绩的预测。这些前瞻性陈述仅用于说明目的,无意作为担保、保证、预测或对事实或概率的明确陈述,也不得被任何投资者作为担保、保证、预测或最终陈述。实际事件和情况很难或无法预测,并且会与假设有所不同。
Any discoveries announced by the Company are based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that any treatment tested by the Company will prove safe or effective in humans, and any clinical benefit of any such treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away.
公司宣布的任何发现仅基于实验室和动物研究。海洋生物医学尚未进行任何显示对人类具有类似疗效或安全性的研究。无法保证该公司测试的任何疗法都会被证明对人体安全或有效,任何此类治疗的任何临床益处都必须经过临床试验,并最终获得美国食品药品管理局对患者的批准。如果获得批准,可能需要数年的时间。
Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include but are not limited to: recently transitioning to operating as a NASDAQ-listed public company with a limited operating history; our ability to successfully complete our pre-clinical trials and for those trials to produce positive results; our ability to timely file and obtain approval of INDs from the FDA in the future; the timing of the initiation, progress and potential results of our planned pre-clinical studies and clinical trials and our research programs; our ability to access additional product candidates from research universities and medical centers; the timing or likelihood of regulatory filings and approvals; the commercializing of our product candidates, if approved; our product development and marketing strategy; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and partnerships, and the potential benefits of such arrangements; our assessment that the early observations from our pre-clinical studies are encouraging; the potential for IND-enabling studies and future clinical trial results to differ from initial results or from our pre-clinical studies; regulatory developments in the United States and other countries; difficulties in managing our growth; our estimates regarding expenses, future revenue, capital requirements and needs for financing and our ability to obtain capital; the sufficiency of our existing and anticipated capital to fund our planned operating expenses; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified professionals; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, product candidates and our pipeline; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic and market conditions; risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; the outcome of any legal proceedings that may be instituted against the Company; the risk of product liability or regulatory lawsuits or proceedings relating to the Company's business; the risk of cyber security or foreign exchange losses; the risk that the Company is unable to secure or protect its intellectual property; the risk that the Company may not be able to develop and maintain effective internal controls; the ability to develop, license, or acquire new therapeutics; the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; and those factors discussed in the Company's filings with the SEC.
前瞻性陈述是基于当前预期和假设的关于未来事件的预测、预测和其他陈述,因此受风险和不确定性的影响。这些前瞻性陈述不能保证未来的业绩、状况或业绩,涉及许多已知和未知的风险、不确定性、假设和其他重要因素,其中许多因素不在公司的控制范围内,可能导致实际结果或结果与前瞻性陈述中讨论的结果或结果存在重大差异。可能影响实际结果或结果的重要因素包括但不限于:最近过渡到在纳斯达克上市的上市公司运营,运营历史有限;我们成功完成临床前试验并使这些试验产生积极结果的能力;我们能够及时向FDA申请并获得INDA的批准;我们计划中的临床前研究和临床试验的启动时间、进展和潜在结果以及我们的研究项目;我们的能力接触来自研究型大学和医学中心的其他候选产品;监管申请和批准的时间或可能性;我们的候选产品如果获得批准,其商业化情况;我们的产品开发和营销策略;如果获得批准,我们成功制造和供应用于临床试验和商业用途的候选产品的能力和潜力;未来的战略安排和/或合作与伙伴关系,以及此类安排的潜在好处;我们的评估是,早期观察结果来自我们的临床前研究令人鼓舞;支持IND的研究和未来的临床试验结果可能与初步结果或我们的临床前研究有所不同;美国和其他国家的监管进展;管理增长方面的困难;我们对支出、未来收入、资本要求和融资需求的估计以及获得资本的能力;我们现有和预期资本是否足以为我们的计划运营支出提供资金;我们保留关键运营持续服务的能力人员以及识别、雇用和留住其他合格专业人员;为我们的业务和产品候选人实施我们的商业模式和战略计划;我们能够为知识产权、候选产品和渠道建立和维持的保护范围;我们与第三方供应商和制造商签订合同的能力及其表现良好的能力;候选产品的定价、覆盖范围和报销(如果获得批准);与竞争对手和行业相关的发展,包括竞争的候选产品和疗法;公司竞争市场的变化,包括竞争格局、技术演变或监管变化;国内和全球总体经济和市场状况的变化;与持续的 COVID-19 疫情和应对措施相关的风险,包括供应链中断;公司可能跟不上快速技术发展的步伐,无法提供新的创新产品和服务,或者对不成功的新产品和服务进行大量投资产品和服务;可能对公司提起的任何法律诉讼的结果;与公司业务有关的产品责任或监管诉讼或诉讼的风险;网络安全或外汇损失的风险;公司无法保护或保护其知识产权的风险;公司可能无法制定和维持有效的内部控制的风险;开发、许可或收购新疗法的能力;公司的风险需要筹集额外资金来执行其商业计划,该计划可能无法以可接受的条件出台或根本无法出台;以及公司向美国证券交易委员会提交的文件中讨论的那些因素。
The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, and which are described in the "Risk Factors" section of the Company's definitive proxy statement filed by the Company on January 12, 2023, and other documents to be filed by the Company from time to time with the SEC and which are and will be available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements.
上述因素清单并不详尽。您应仔细考虑上述因素以及公司不时向美国证券交易委员会提交的10-K表年度报告中描述的其他风险和不确定性,这些因素在公司于2023年1月12日提交的公司最终委托书的 “风险因素” 部分以及公司不时向美国证券交易委员会提交的其他文件中进行了描述,这些文件现在和将在www.sec.gov上公布。这些文件确定并解决了其他重要的风险和不确定性,这些风险和不确定性可能导致实际事件和结果与前瞻性陈述中包含的事件和结果存在重大差异。前瞻性陈述仅代表其发表之日。提醒读者不要过分依赖前瞻性陈述。自提交本文件之日起,不得将这些前瞻性陈述作为公司评估的依据。因此,不应过分依赖前瞻性陈述。
Ocean Biomedical Investor Relations
OCEANIR@westwicke.com
海洋生物医学投资者关系
OCEANIR@westwicke.com
Ocean Biomedical Media Relations
OCEANPR@westwicke.com
海洋生物医学媒体关系
OCEANPR@westwicke.com
Kevin Kertscher
Communications Director
凯文·克切尔
传播总监