The CaCo-2 cell junction derangement exerted by the single addition of oxysterols commonly detected in foods is markedly quenched when they are in mixture

Article

作者: Gamba, Paola ; Biasi, Fiorella ; Poli, Giuseppe ; Menta, Roberto ; Iaia, Noemi ; Canzoneri, Federico ; Testa, Gabriella

The selective permeability of the gut epithelial barrier is heavily reliant on the stability of cell junctions, often challenged by a variety of dietary stressors, including non-enzymatic cholesterol oxidation products (COPs). A marked decrease of the tight junctions claudin-1 and occludin, and of the adherens junction E-cadherin was previously detected in differentiated CaCo-2 monolayers challenged by a single addition of 7β-hydroxycholesterol (7βOHC) or 7-ketocholesterol (7KC) in the lowest micromolar range. However, in the diet, oxysterols are occurring in a mixture. Hence, the aim of the present study was to evaluate whether cell incubation with all the main dietary COPs together quench the intercellular junction derangement previously observed as exerted by 7βOHC and 7KC singularly added. Two chocolate prototypes, respectively made with fresh (oxy-Mix1) or six-months stored whole milk powder (oxy-Mix2), were compared. The second prototype showed an almost double content of total COPs (3.34 µM, approximately 1337 ng /g of chocolate) than the first one (1.69 µM, approximately 675 ng /g of chocolate). Importantly, even in the CaCo-2 cell monolayers treated with six-months stored mixture of COPs oxy-Mix2, no alterations were observed of those cell junctions markedly affected by identical concentration of 7βOHC or 7KC used alone. The junctions' derangement started to be significantly evident when oxy-Mix2 was used at higher concentration (5 µM, approximately 2 µg oxysterols/g of product) or when treatments were carried out with repeated doses of oxy-Mix2 every 24 hours. Although achieved in a still widely adopted in vitro model system, these findings could orientate the definition of a safe shelf-life for dairy products, certainly for milk chocolate.

2025-01-01·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Interactions of sphingomyelin with biologically crucial side chain-hydroxylated cholesterol derivatives

Article

作者: Chachaj-Brekiesz, Anna ; Kobierski, Jan ; Dynarowicz-Latka, Patrycja ; Lipiec, Ewelina W ; Lupa, Dawid ; Wnętrzak, Anita ; Lipiec, Ewelina W. ; Półtorak, Andżelika

Oxysterols are interesting molecules due to their dual nature, reflecting beneficial and harmful effects on the body. An issue that still needs to be solved is how slight modification of their structure owing to the location of the additional polar group in the molecules affects their biological activity. With this in mind, we selected three side chain-hydroxylated oxysterols namely: 20(S)-hydroxycholesterol (20(S)-OH), 24(S)-hydroxycholesterol (24(S)-OH), and 27-hydroxycholesterol (27-OH), and examined their behavior in mixtures with the bioactive sphingolipid - sphingomyelin (SM). Our research was based on the Langmuir monolayer technique supplemented with molecular dynamics (MD) and microscopic observation of the films texture (Brewster angle microscopy, BAM, and atomic force microscopy, AFM). Additionally, since 20(S)-hydroxycholesterol has not been studied so far, we thoroughly characterized this oxysterol in one-component monolayers. Our studies showed differences in the interactions of the studied oxysterols and sphingomyelin. Namely, it was found that 20(S)-OH binds to SM, unlike 24(S)-OH and 27-OH, which both weakly interact with SM. This distinct behavior was interpreted within the molecular dynamics as being due to weak intermolecular interactions between 20(S)-OH molecules, which allowed easy incorporation of SM into the 20(S)-OH monolayer. In contrast, the strong oxysterol-oxysterol interactions occurring in monolayers with 24(S)-OH or 27-OH make this process more difficult. This may be important in the process of bone formation/resorption. Other aspects derived from our study are: (i) the tendency of oxysterols to incorporate into lipid rafts (leading to their modification in structure and function), as well as (ii) the formation of multilayer structures, in which oxysterols are arranged in the characteristic forms of "strings of beads", which may facilitate their transport across the membrane.

2024-10-22·ACS Nano

Immune Implications of Cholesterol-Containing Lipid Nanoparticles

Review

作者: La-Beck, Ninh M. ; Schwendeman, Anna A. ; Modaresahmadi, Shadan ; Back, Patricia Ines ; Yu, Minzhi ; Zhang, Qisheng ; Hajimirzaei, Sahelosadat ; Islam, Md Rakibul

The majority of clinically approved nanoparticle-mediated therapeutics are lipid nanoparticles (LNPs), and most of these LNPs are liposomes containing cholesterol. LNP formulations significantly alter the drug pharmacokinetics (PK) due to the propensity of nanoparticles for uptake by macrophages. In addition to readily engulfing LNPs, the high expression of cholesterol hydroxylases and reactive oxygen species (ROS) in macrophages suggests that they will readily produce oxysterols from LNP-associated cholesterol. Oxysterols are a heterogeneous group of cholesterol oxidation products that have potent immune modulatory effects. Oxysterols are implicated in the pathogenesis of atherosclerosis and certain malignancies; they have also been found in commercial liposome preparations. Yet, the in vivo metabolic fate of LNP-associated cholesterol remains unclear. We review herein the mechanisms of cellular uptake, trafficking, metabolism, and immune modulation of endogenous nanometer-sized cholesterol particles (i.e., lipoproteins) that are also relevant for cholesterol-containing nanoparticles. We believe that it would be imperative to better understand the in vivo metabolic fate of LNP-associated cholesterol and the immune implications for LNP-therapeutics. We highlight critical knowledge gaps that we believe need to be addressed in order to develop safer and more efficacious lipid nanoparticle delivery systems.

项与 Oxysterols(Centre National de la Recherche Scientifique) 相关的新闻（医药）

2024-10-24

·PRNewswire

MAX BioPharma announces key update on its anti-fibrotic and anti-inflammatory oxysterol drug candidate that inhibits MASH, atherosclerosis, and fat tissue inflammation

MAX BioPharma is Pursuing Strategic Partnerships and Series A Financing LOS ANGELES, Oct. 24, 2024 /PRNewswire/ -- MAX BioPharma, Inc. ( ) recently published an article demonstrating the anti-atherosclerotic, anti-inflammatory, and cholesterol-lowering effects of its orally bioavailable oxysterol lead compound, Oxy210, in the peer-reviewed journal, Cells. Oxy210 is derived from the Company's Oxysterol Therapeutics® platform of proprietary small molecule oxysterols that has enabled discovery of diverse oxysterol-based drug candidates in different therapeutic areas, such as bone regeneration, viral and bacterial infection, cancer, pathologic fibrosis, and chronic inflammation. Oxy210 displays unique mechanisms of action that mediate its anti-inflammatory and anti-fibrotic effects based on multipronged targeting of not just one, but multiple cellular signaling pathways. When dysregulated, these vital signals are known to drive the progression of complex diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and its comorbidity, atherosclerosis, which is the leading cause of death in people with MASH. Continue Reading During previous research conducted at the David Geffen School of Medicine at the University of California, Los Angeles and directed by Principal Investigator Dr. Jake Lusis, Professor of Medicine, and Dr. Simon Hui, Project Scientist, Oxy210 was found to significantly inhibit the development of fibrosis in a humanized mouse model of MASH that involves progressive inflammation, fat deposition, and fibrosis in the livers of these mice. The inhibition of fibrosis by Oxy210 was associated with reduced hepatic lipid deposition and the inhibited expression of pro-fibrotic and pro-inflammatory factors including transforming growth factor beta (TGF-β), NLRP3 inflammasome, interleukin-6 (IL-6), tumor necrosis alpha (TNF-α), interleukin-1 beta (IL-1β) and monocyte chemotactic protein 1 (MCP-1). Moreover, Oxy210 inhibited adipose tissue inflammation, suggesting its anti-inflammatory potential that reaches beyond the liver. In their recently published article, the investigators report on significant inhibition of atherosclerosis, a chronic inflammatory disease, in addition to parallel inhibition of MASH. Treatment with Oxy210 was associated with lowering circulating cholesterol levels and reducing macrophage proliferation and content in the artery wall. Together with the in vitro findings of the anti-inflammatory effects of Oxy210 in aortic endothelial cells and macrophages, it appears that Oxy210 could be a promising drug candidate for targeting MASH, atherosclerosis, and perhaps other chronic inflammatory diseases associated with metabolic dysfunction. An anti-inflammatory, anti-fibrotic, cholesterol-lowering oxysterol drug candidate targeting MASH and atherosclerosis Post this "There is an urgent need for therapies to treat fatty liver disease and its more advanced form, MASH, and I find the results of our studies with MAX BioPharma quite exciting" states Dr. Lusis. "Our humanized hyperlipidemic mouse model of MASH reflects the natural history of metabolic dysfunction-associated steatotic liver disease (MASLD) progression in humans and reproduces the salient features of human MASH. Attenuation of hepatic fibrosis and inflammation, as well as anti-atherosclerotic effects suggest that Oxy210 should be further explored as a therapeutic candidate for targeting both conditions " explains Dr. Hui." Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma, comments: "Oxysterol-based molecules have been our treasure-trove, driving the Company's drug discovery efforts across several therapeutic indications", adding that "Surprisingly, Oxy210 acts a bit like a Swiss-army knife by combining anti-inflammatory, anti-fibrotic, and lipid-lowering effects, a rare combination of helpful properties". Additional pre-clinical studies required by the FDA for clinical development of Oxy210 are currently underway at MAX BioPharma and the Company is seeking strategic partnerships with biotechnology and pharmaceutical companies with the expertise and resources to further the development of oxysterol-based molecules towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A tranche financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for MASH, a condition with currently only one FDA-approved treatment, indicated for non-cirrhotic MASH and apparently effective in less than 30% of patients. Nevertheless, with dozens of failed clinical drug candidate in this field, this first ever FDA-approved drug reintroduced some degree of hope for people suffering with this condition, once considered untreatable" says Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma, adding "we hope to continue the advancement of MASH therapeutics with our novel drug candidate". About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel small molecule lipids as drug candidates for intervention in debilitating and fatal human diseases. The company will be a leader in a new field of Oxysterol Therapeutics® by leveraging a robust and growing intellectual property portfolio that will lead to treatments for numerous indications. MAX BioPharma's first success based on small molecule lipids has contributed to the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGF-b pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung and pancreatic cancer, and hematologic malignancies, as well as fibrotic diseases of liver, lung, and kidney among others. For more information, please visit us at Media Contact: Farhad Parhami [email protected] SOURCE MAX BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-02-26

·BioSpace

MAX BioPharma and Metaba Announce Collaboration on Metabolomics Studies

LOS ANGELES, Feb. 26, 2024 /PRNewswire/ -- Today MAX BioPharma, Inc. ( ) and Metaba, LLC ( ) announced their collaboration in studying the effects of oxysterol drug candidates that target non-alcoholic steatohepatitis (NASH), idiopathic pulmonary fibrosis (IPF), chronic inflammation, and atherosclerosis on metabolic processes using Metaba's state of the art metabolomics platform technology. The two companies will employ their unique expertise and assets to identify changes in metabolites induced by oxysterols that may not only further evaluate the mechanism of action for their therapeutic effects, but also identify potential biomarkers for assessment of the efficacy of the compounds or as diagnostic and prognostic tools. "We are extremely excited about this important collaboration between our companies and scientists that will empower MAX BioPharma in its R&D efforts to develop novel drugs for some of the most debilitating and fatal diseases in humans, especially NASH that currently has no FDA approved therapies, IPF that is only modestly affected by the existing FDA approved drugs, and cardiovascular diseases that remain a huge problem despite the use of cholesterol lowering drugs and lifestyle changes. In addition, as we pursue our goals in developing novel drugs, it is imperative that we also find less invasive ways to assess their efficacy both in preclinical models of the diseases and in future human clinical trials" says Farhad Parhami, President and CEO of MAX BioPharma. Dr. Parhami will be presenting the company's recent developments at the 2024 Biocom Global Partnering & Venture Conference that will take place from February 27th-29th in La Jolla, California. Philip Sell, CEO of Metaba explains: "Metabolomics is a powerful research tool. It fills in the missing gap to complete the multi-omics approach to research and is widely applicable to studying diverse biological systems. Our platform can aid development efforts by helping our scientists to understand the underlying molecular mechanisms of pathogenesis, disease progression, therapeutic action, adjunctive targets, and novel diagnostic or prognostic biomarkers. We are enthusiastic about our collaboration with MAX BioPharma and the value that we can add to their already impressive therapeutic development programs. Our companies synergize elegantly with the unique expertise that each brings to the table. We look forward to combining our efforts to make an impact on debilitating diseases and ultimately improving the patient experience." About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel lipid molecules as drug candidates for debilitating and fatal human diseases. The company has created the Oxysterol Therapeutics® platform, which is applicable across numerous therapeutic indications, and is leveraging a robust and growing intellectual property portfolio. MAX BioPharma's first entry into this area was through the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of orally bioavailable small molecule oxysterols that function as anti-tumorigenic Hedgehog and transforming growth factor-beta (TGF-ß) pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung, blood and pancreatic cancer, as well as fibrotic diseases of liver, lung, and kidney, in addition to those that have antiviral activity against hepatitis B and C viruses and coronaviruses. For more information, please visit us at About Metaba, LLC. Metaba is a privately held biotechnology company based in Santa Monica, California. Metaba has created a novel drug discovery platform that combines a high-powered metabolomics analysis pipeline with computer aided drug design methods to expedite preclinical research and development timelines. Metaba was originally founded to develop an adjunctive therapeutic for treatment of tuberculosis (TB). Building upon the methodological approach that their scientists used to identify a novel drug target in TB and their expertise in metabolomics, the platform was born. Metaba has since expanded their capabilities to address several other indications for drug development including nontuberculosis mycobacteria (NTM), immune response to viral infection (Influenza and Covid-19), metabolism of new drugs, and enhancing multiple development programs of MAX BioPharma. The company has focused on developing novel small molecules as drug candidates and is also interested in exploring use cases of its novel metabolomics analysis platform. For more information, please visit us at View original content to download multimedia: SOURCE MAX BioPharma

2023-09-21

·GlobeNewswire-Health Care

NewAmsterdam Pharma Announces Initial Data from Phase 2a Clinical Trial Evaluating Obicetrapib in Patients with Early Alzheimer’s Disease Who Carry an ApoE4 Mutation

-- Observed reductions of 11% and 12% in 24- and 27-hydroxycholesterol in cerebrospinal fluid (“CSF”), respectively, indicating potential improvement of cholesterol metabolism in the brain -- -- Observed 8% increase in Aβ42/40 ratio, a key biomarker of AD risk, suggesting improvement in disease pathology -- NAARDEN, The Netherlands and MIAMI, Sept. 21, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced initial data from its Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease (“AD”) and at least one copy of the apolipoprotein E4 mutation (“ApoE4”). This Phase 2a trial was designed to explore the effects of obicetrapib on lipid metabolism in the brains of early AD patients who are ApoE4 carriers. Two key biomarkers measured in the trial include 24- and 27-hydroxycholesterol; increases in these oxysterols over time have been observed to lead to a rise in cognitive and related functional impairment. As such, NewAmsterdam believes reductions of 24- and 27-hydroxycholesterol in the CSF may indicate improved cholesterol metabolism in the brain and may lead to improved cognitive function. In addition, the Phase 2a trial assessed the Aβ42/40 ratio and plasma pTau181, also believed to be biomarkers of AD, with lower levels of Aβ42/40 and increased levels of pTau181 having been associated with a greater risk of AD. This trial builds on observations from NewAmsterdam’s preclinical studies and third-party genetic studies that inhibiting cholesteryl ester transfer protein (“CETP”) may protect against ApoE4-associated AD risk by preventing the accumulation of amyloid plaque in the brain through improved cholesterol metabolism and, as a result, potentially slow disease progression. “These data represent an important first step in determining the role of lipid metabolism in the brain,” said Jeffrey Cummings, M.D., Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas. “Approximately two thirds of patients with Alzheimer’s dementia carry at least one copy of the ApoE4 gene and CETP loss-of-function mutations have been shown to protect against ApoE4-associated AD risk. These data warrant further study of CETP inhibition as a potential mechanism to ameliorate ApoE4-associated AD risk.” Initial Data from the Phase 2a Alzheimer’s Trial “We are encouraged by our initial data, in which we observed reductions in CSF levels of 24- and 27-hydroxycholesterol in the 13 patients treated in the trial. We believe increased CSF levels of these oxysterols may be linked to neuroinflammation and Alzheimer’s pathology,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are particularly pleased that this observed reduction in 24- and 27-hydroxycholesterol was paired with an eight percent improvement in the Aβ42/40 ratio. Based on these initial results, we believe obicetrapib could offer a meaningful advancement for a high-risk patient population with limited available treatment options and look forward to working to further characterize its potential for AD in an efficient, cost-effective manner through our ongoing clinical trials.” The open-label and single-arm trial was designed to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of obicetrapib 10 mg in early AD patients carrying at least one copy of ApoE4. A total of 13 patients were given 10 mg obicetrapib and followed for 24 weeks. NewAmsterdam observed reductions in the levels of 24- and 27-hydroxycholestrol of 11% and 12%, respectively, in the CSF. In addition, an increase of 8% in the Aβ42/40 ratio in patient’s plasma was observed and pTau181 levels were observed to be stable. Overall, obicetrapib was observed to be well-tolerated. No serious adverse events (“AEs”) were reported, nor were any AEs considered to be related to the study drug. “Together, we believe these observations suggest that potent CETP inhibition may offer a novel approach to reducing the risk of AD in ApoE4 carriers. In this small trial, treatment with obicetrapib was observed to reduce levels of 24- and 27-hydrocholestrol and increase the ratio of Aβ42/40 in plasma, supporting our belief that improved brain cholesterol metabolism correlates with removal of amyloid beta peptides which ultimately might lead to improved cognition,” said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. NewAmsterdam anticipates sharing the full results of this Phase 2a clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting and plans to seek feedback from the U.S. Food and Drug Administration to inform the potential further development of obicetrapib for the treatment of AD. About ObicetrapibObicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In the Company’s Phase 2b ROSE trial, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins and, in the Company’s Phase 2 ROSE2 trial, the combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe demonstrated a 63% lowering of LDL-C from baseline. In all five of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, OCEAN, and TA-8995-203, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo, including no increase in blood pressure or muscle related side effects. Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels (“dyslipidemia”) in NewAmsterdam’s clinical trials to date. The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for high-risk cardiovascular disease (“CVD”) patients. The Company began enrolling patients in BROADWAY in January 2022 and in BROOKLYN in July 2022 and completed enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. About NewAmsterdam Based in the Netherlands, NewAmsterdam (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been sufficiently adequate or well tolerated. NewAmsterdam seeks to fill a significant unmet need for a safe, cost-effective and convenient LDL-lowering therapy as an adjunct to statins, a class of lipid-lowering medications that are the current standard of care for high-risk CVD patients with high cholesterol. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease patients. Forward-Looking Statements Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s business and strategic plans, the Company’s commercial opportunity, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and 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 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 may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company Contact Matthew Philippe matthew.philippe@newamsterdampharma.com Media Contact Spectrum Science on behalf of NewAmsterdam Jenn Gordon P: 1-202-957-7795 jgordon@spectrumscience.com Investor Contact Stern Investor Relations on behalf of NewAmsterdam Hannah Deresiewicz P: 1 212-362-1200 hannah.deresiewicz@sternir.com

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ARVO2008	N/A	-	-	Oxysterols (ARPE19 cells)	築衊淵鹹淵淵構襯憲鏇(製鹽窪膚鹹醖積廠餘簾) = 遞構餘選遞憲構淵襯夢願鬱觸廠構鬱齋襯膚獵 (鏇鑰製遞遞襯觸範鑰淵 ) 更多	-	2008-05-01
				Oxysterols (D407 cells)	築衊淵鹹淵淵構襯憲鏇(製鹽窪膚鹹醖積廠餘簾) = 鹽鏇願積積鬱選鏇鹹憲願鬱觸廠構鬱齋襯膚獵 (鏇鑰製遞遞襯觸範鑰淵 ) 更多