Phase 3, Multicenter, Randomized, 48 Week, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate Efficacy and Safety of CER-001 on Vessel Wall Area in Patients With Genetically Defined Familial Primary Hypoalphalipoproteinemia

The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.

Start Date01 Dec 2015

Sponsor / Collaborator

Cerenis Therapeutics, Inc.

NCT02484378 / CompletedPhase 2

CER-001 Atherosclerosis Regression ACS Trial; A Phase II Multi-Center, Double-Blind, Placebo-Controlled, Dose-Focusing Trial Of Cer-001 In Subjects With Acute Coronary Syndrome

The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.

Start Date01 Aug 2015

Sponsor / Collaborator

Cerenis Therapeutics, Inc.

[+1]

NCT01515241 / CompletedPhase 2

EXPLORATORY STUDY OF PLAQUE REGRESSION:A Phase II Single Center Open-Label Exploratory Trial of the Effect of CER 001 in Subjects With Familial Hypercholesterolemia

Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies. There are a number of therapies given on a chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for cardiovascular events. There is still a need for acute therapies that can lead to rapid pacification of unstable plaque in order to reduce the risk of these events. This study will assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and intravascular ultrasound (IVUS) evaluations in patients with HeFH.

Start Date01 Jan 2012

Sponsor / Collaborator

Cerenis Therapeutics, Inc.

100 Clinical Results associated with Cerenis Therapeutics, Inc.

0 Patents (Medical) associated with Cerenis Therapeutics, Inc.

Literatures (Medical) associated with Cerenis Therapeutics, Inc.

01 Jan 2014·AtherosclerosisQ2 · MEDICINE

CER-001, a HDL-mimetic, stimulates the reverse lipid transport and atherosclerosis regression in high cholesterol diet-fed LDL-receptor deficient mice

Q2 · MEDICINE

Article

Author: Lalwani, Narendra ; Goffinet, Marine ; Barbaras, Ronald ; Baron, Rudi ; Cholez, Guy ; Sy, Gavin ; Keyserling, Constance ; Bluteau, Alice ; Dasseux, Jean-Louis ; Boubekeur, Nadia ; Tardy, Claudine ; Ackermann, Rose ; Paolini, John F

OBJECTIVECER-001 is a novel engineered HDL-mimetic comprised of recombinant human apoA-I and phospholipids that was designed to mimic the beneficial properties of nascent pre-β HDL. In this study, we have evaluated the capacity of CER-001 to perform reverse lipid transport in single dose studies as well as to regress atherosclerosis in LDLr(-/-) mice after short-term multiple-dose infusions.APPROACH AND RESULTSCER-001 induced cholesterol efflux from macrophages and exhibited anti-inflammatory response similar to natural HDL. Studies with HUVEC demonstrated CER-001 at a concentration of 500 μg/mL completely suppressed the secretion of cytokines IL-6, IL-8, GM-CSF and MCP-1. Following infusion of CER-001 (10mg/kg) in C57Bl/6J mice, we observed a transient increase in the mobilization of unesterified cholesterol in HDL particles containing recombinant human apoA-I. Finally we show that cholesterol elimination was stimulated in CER-001 treated animals as demonstrated by the increased cholesterol concentration in liver and feces. In a familial hypercholesterolemia mouse model (LDL-receptor deficient mice), the infusion of CER-001 caused 17% and 32% reductions in plaque size, 17% and 23% reductions in lipid content after 5 and 10 doses given every 2 days, respectively. Also, there was an 80% reduction in macrophage content in the plaque following 5 doses, and decreased VCAM-1 expression by 16% and 22% in the plaque following 5 and 10 intravenous doses of CER-001, respectively.CONCLUSIONThese data demonstrate that CER-001 rapidly enhances reverse lipid transport in the mouse, reducing vascular inflammation and promoting regression of diet-induced atherosclerosis in LDLr(-/-) mice upon a short-term multiple dose treatment.

PLOS ONEQ3 · CROSS-FIELD

HDL and CER-001 Inverse-Dose Dependent Inhibition of Atherosclerotic Plaque Formation in apoE-/- Mice: Evidence of ABCA1 Down-Regulation

Q3 · CROSS-FIELD

ArticleOA

Author: Paolini, John F ; Goffinet, Marine ; Lalwani, Narendra ; Keyserling, Constance ; Baron, Rudi ; Barbaras, Ronald ; Sy, Gavin ; Dasseux, Jean-Louis ; Cholez, Guy ; Boubekeur, Nadia ; Ackermann, Rose ; Tardy, Claudine

OBJECTIVECER-001 is a novel engineered HDL-mimetic comprised of recombinant human apoA-I and charged phospholipids that was designed to mimic the beneficial properties of nascent pre-ß HDL. In this study, we have evaluated the dose-dependent regulation of ABCA1 expression in vitro and in vivo in the presence of CER-001 and native HDL (HDL3).METHODS AND RESULTSCER-001 induced cholesterol efflux from J774 macrophages in a dose-dependent manner similar to natural HDL. A strong down-regulation of the ATP-binding cassette A1 (ABCA1) transporter mRNA (- 50%) as well as the ABCA1 membrane protein expression (- 50%) was observed at higher doses of CER-001 and HDL3 compared to non-lipidated apoA-I. In vivo, in an apoE-/- mouse "flow cessation model," in which the left carotid artery was ligatured to induce local inflammation, the inhibition of atherosclerotic plaque burden progression in response to a dose-range of every-other-day CER-001 or HDL in the presence of a high-fat diet for two weeks was assessed. We observed a U-shaped dose-response curve: inhibition of the plaque total cholesterol content increased with increasing doses of CER-001 or HDL3 up to a maximum inhibition (- 51%) at 5 mg/kg; however, as the dose was increased above this threshold, a progressively less pronounced inhibition of progression was observed, reaching a complete absence of inhibition of progression at doses of 20 mg/kg and over. ABCA1 protein expression in the same atherosclerotic plaque was decreased by-45% and-68% at 50 mg/kg for CER-001 and HDL respectively. Conversely, a-12% and 0% decrease in ABCA1 protein expression was observed at the 5 mg/kg dose for CER-001 and HDL respectively.CONCLUSIONSThese data demonstrate that high doses of HDL and CER-001 are less effective at slowing progression of atherosclerotic plaque in apoE-/- mice compared to lower doses, following a U-shaped dose-response curve. A potential mechanism for this phenomenon is supported by the observation that high doses of HDL and CER-001 induce a rapid and strong down-regulation of ABCA1 both in vitro and in vivo. In conclusion, maximally efficient HDL- or CER-001-mediated cholesterol removal from atherosclerotic plaque is achieved by maximizing macrophage-mediated efflux from the plaque while minimizing dose-dependent down-regulation of ABCA1 expression. These observations may help define the optimal dose of HDL mimetics for testing in clinical trials of atherosclerotic burden regression.

PLoS ONEQ3 · CROSS-FIELD

P2Y13 Receptor Regulates HDL Metabolism and Atherosclerosis In Vivo

Q3 · CROSS-FIELD

ArticleOA

Author: Lalwani, Narendra D ; Baron, Rudi ; Oniciu, Daniela C ; Barbaras, Ronald ; Boubekeur, Nadia ; Cholez, Guy ; Bluteau, Alice ; Dasseux, Jean-Louis H ; Tardy, Claudine ; Goffinet, Marine

High-density lipoprotein (HDL) is known to protect against atherosclerosis by promoting the reverse cholesterol transport. A new pathway for the regulation of HDL-cholesterol (HDL-c) removal involving F1-ATPase and P2Y13 receptor (P2Y13R) was described in vitro, and recently in mice. However, the physiological role of F1-ATPase/P2Y13R pathway in the modulation of vascular pathology i.e. in the development of atherosclerotic plaques is still unknown. We designed a specific novel agonist (CT1007900) of the P2Y13R that caused stimulation of bile acid secretion associated with an increased uptake of HDL-c in the liver after single dosing in mice. Repeated dose administration in mice, for 2 weeks, stimulated the apoA-I synthesis and formation of small HDL particles. Plasma samples from the agonist-treated mice had high efflux capacity for mobilization of cholesterol in vitro compared to placebo group. In apoE-/- mice this agonist induced a decrease of atherosclerotic plaques in aortas and carotids. The specificity of P2Y13R pathway in those mice was assessed using adenovirus encoding P2Y13R-shRNA. These results demonstrate that P2Y13R plays a pivotal role in the HDL metabolism and could also be a useful therapeutic agent to decrease atherosclerosis. In this study, the up-regulation of HDL-c metabolism via activation of the P2Y13R using agonists could promote reverse cholesterol transport and promote inhibition of atherosclerosis progression in mice.

News (Medical) associated with Cerenis Therapeutics, Inc.

17 Jan 2023

·www.fiercebiotech.com

Abionyx hails success of bid to resurrect failed cholesterol drug—without dishing data to back up claims

Shares in Abionyx Pharma rose around 15% in early trading in Paris. Abionyx Pharma has hailed the success of a phase 2a clinical trial designed to resurrect a cholesterol drug that first flamed out almost a decade ago. But with the French biotech yet to share numbers from the study, it is unclear whether the mimic of HDL cholesterol has a future in the treatment of septic patients. Cerenis Therapeutics originally developed the drug candidate, CER-001, as a treatment for cardiovascular diseases. The wheels came off between 2014 and 2018 when the prospect failed to move the needle in phase 2 and 3 trials of patients with acute coronary disease, post-acute coronary syndrome and genetic HDL deficiency. Cerenis rebranded as Abionyx in 2019 and shifted its focus to other indications. A phase 2a clinical trial in septic patients at high risk of developing acute kidney injury is an early test of the pivot. Abionyx said CER-001 cleared the test—but the data-devoid statement published by the biotech makes it impossible for outsiders to fully gauge how the candidate performed in the trial. According to Abionyx, the study met its primary objective. The EU clinical trial registry lists the co-primary endpoints of the trial as determination of the optimal dose and the onset and severity of acute kidney injury. The study’s lead investigator noted the “trend observed in reducing renal damage” in a statement to disclose the results. Abionyx also noted “positive results” on secondary endpoints. The biotech reported a “significant effect” on endotoxin removal and “consequent reduction in the inflammatory cascade,” plus a “significant protective effect … on endothelial functionality” and trends toward fewer ICU days, lower requirement for organ support and improved 30-day survival. Safety was reportedly in line with the results of a COVID-19 trial that read out last year. Abionyx is yet to say when it will present the full data set but did outline plans to discuss the results with regulators, first in Europe and later in the U.S., “to design an appropriate clinical and regulatory development strategy for this disease state.” Abionyx will need to secure funding for further development. The biotech ended September with just 3.8 million euros ($4.1 million) to its name. Shares in Abionyx rose around 15% in early trading in Paris, climbing to 2.22 euros per share.

Phase 2Financial StatementClinical ResultClinical Trial Failure

21 Jun 2022

·www.prnewswire.com

Acute Kidney Injury Market to Grow at a CAGR of Approximately 8% by 2032 | DelveInsight

The dynamics of acute kidney injury market is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, incremental healthcare spending across the world and the expected launch of the emerging therapies during the forecast period. LAS VEGAS, June 21, 2022 /PRNewswire/ -- DelveInsight's Acute Kidney Injury Market Insights report includes a comprehensive understanding of current treatment practices, Acute Kidney Injury emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan. Key Takeaways from the Acute Kidney Injury Market Report As per DelveInsight analysis, the Acute Kidney Injury market size in the 7MM was approximately USD 5.4 billion in 2020. As per DelveInsight analysis, the total Acute Kidney Injury incident cases in the 7MM were approximately 10.9 million in 2020. The United States contributed to the largest incident-patient share (mortality adjusted), acquiring ~ 34.09% of the 7MM in 2020 Rising incidence of AKI will provide a larger window of opportunity for new treatment and prevention options The pipeline of AKI is quite robust with diverse products strengthening targeting prophylaxis of AKI in several complications such as Sepsis and post-cardiac-surgery mainlyLeading acute kidney injury companies such as Cerenis Therapeutics, Alloksys, Vifor Pharma, Exponential Biotherapies, Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, Nephraegis Therapeutics, Vasomune, Unicycive, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Astellas Pharma, Amniotics, Mission Therapeutics, Bessor pharma, Kantum Pharma, ABIONYX, and others are developing novel drug candidates to improve the Acute Kidney Injury treatment landscape. The Acute Kidney Injury therapies in the pipeline include bRESCAP, ANG-3777, EA-230, Ilofotase alfa, ASP1128, Ruconest (Conestat alfa) , and others. The key driver for the surge in acute kidney injury market size is the rise in the number of incident cases of acute kidney injury. Discover more about therapies set to grab major acute kidney injury market share @ Acute Kidney Injury Market Landscape Acute Kidney Injury Overview Acute kidney injury (AKI), also known as acute renal failure (ARF), is a disorder that causes progressive azotemia with or without oliguria over a period of hours or days. Acute kidney injury is defined as a sudden loss of renal function, clinically expressed as an acute reversible surge in nitrogen waste products as measured by blood urea nitrogen and serum creatinine levels over hours to weeks. Acute kidney injury causes an abrupt loss in renal function, which results in waste product retention, electrolyte abnormalities, and changes in volume status. Acute kidney injury is classified into prerenal, postrenal, and intrinsic renal. Many people with acute kidney injury are asymptomatic, while others experience generalized non-specific acute kidney injury symptoms such as nausea, vomiting, weakness, dizziness, lower back pain, passing less urine than usual, unexplained loss of appetite, feeling sick or vomiting, shortness of breath, and swelling of the legs or other body parts. An increase in serum creatinine and a reduction in urine output are commonly used for acute kidney injury diagnosis. Acute Kidney Injury Epidemiology Segmentation As per DelveInsight, there were approx 10.9 million acute kidney injury incident cases in the 7MM in 2020. Among the EU5 countries, Germany had the highest acute kidney injury incident population in 2020. The Acute Kidney Injury market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into Total Incident Population of Acute Kidney Injury (AKI) in Hospitalized Patients Mortality Adjusted Incident Population of AKI in Hospitalized Patients Stage-specific Incident Population of AKI Age-specific Incident Population of AKI Download the report to understand which factors are driving acute kidney injury epidemiology trends @ Acute Kidney Injury Epidemiological Insights Acute Kidney Injury Treatment Market For the past several years; it has been observed that the current acute kidney injury treatment is primarily supportive in character, with no therapeutic approaches demonstrating benefit in treating the condition. Off-label acute kidney injury medications used to treat AKI include ACE inhibitors, angiotensin II-receptor blockers (ARBs), diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), and renal replacement therapy (RRT). Monitoring urine output and, at first, serum creatinine levels (SCr) numerous times each day is a cornerstone of the therapy for all patients with acute kidney injury. It is also indicated to correct electrolyte imbalances, quit or adjust nephrotoxic medicines, and dose-adjust pharmaceuticals with renal elimination. To know more about Acute Kidney Injury treatment, visit @ Acute Kidney Injury Guidelines Acute Kidney Injury Pipeline Therapies and Key Companies bRESCAP: Alloksys ANG-3777 (BB3): Angion Biomedica/ Vifor Pharma EA-230: Exponential Biotherapies Ilofotase alfa: AM Pharma ASP1128: Astellas Pharma Ruconest (Conestat alfa): Pharming Technologies Learn more about the acute kidney injury medications @ Drugs for Acute Kidney Injury Acute Kidney Injury Market Dynamics Treatment-related adverse effects are quite rare, resulting in successful acute kidney injury treatment choices. Moreover, patients have easy access to reimbursements since their ailment necessitates long-term management, such as dialysis. In addition, several government activities are being undertaken by adopting various programs concerning acute kidney injury, which is expected to improve the global AKI prospect and thus bolster the actue kidney injury market. Furthermore, several biomarkers, including NGAL, Cystatin-C, and others, are being investigated for use in acute kidney injury diagnosis. The validation of these new biomarkers could provide new methods for detecting the start and severity of kidney injury. Future research in the acute kidney injury market is underway with the goal of better understanding of the underlying processes and, as a result, improve outcomes for AKI patients. Moreover, a robust pipeline with a novel mechanism of action and increasing incidence are major market drivers of the acute kidney injury market. Additionally, the acute kidney injury pipeline is also expected to change the current dynamics of the acute kidney injury market, which presently comprises biologics and molecules with new mechanisms of action like ANG-3777 (BB3), ASP1128, Ilofotase alfa, Ruconest (Conestat alfa), bRESCAP, EA230, and others. However, there are several barriers to the acute kidney injury market growth. One such factor is the lack of awareness. If the patients have cardiac issues, the situation becomes even more complex. Moreover, long-term health repercussions, as well as longer hospital stays and high health-care expenses, highlight AKI's enormous societal impact. In addition, several risk factors, such as diabetes and heart failure, have substantial implications for patients' quality of life, making it challenging to develop promising future interventions and thus hindering the acute kidney injury market growth. Scope of the Acute Kidney Injury Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Acute Kidney Injury Companies: Cerenis Therapeutics Alloksys, Vifor Pharma, Exponential Biotherapies, Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, Nephraegis Therapeutics, Vasomune, Unicycive, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Astellas Pharma, Amniotics, Mission Therapeutics, Bessor pharma, Kantum Pharma, ABIONYX, and others Key Acute Kidney Injury Therapies: bRESCAP, ANG-3777, EA-230, Ilofotase alfa, ASP1128, Ruconest (Conestat alfa), and others Therapeutic Assessment: Acute kidney injury current marketed and emerging therapies Acute Kidney Injury Market Dynamics: Acute kidney injury market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Acute Kidney Injury Market Access and Reimbursement Discover more about acute kidney injury drugs in development @ Acute Kidney Injury Clinical Trials Table of Contents Get in touch with our Business executive @ Healthcare Due Diligence Services Related Reports Acute Kidney Injury Pipeline Acute Kidney Injury Pipeline Insight, 2022 report provides comprehensive insights about pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key acute kidney injury companies including Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, LG Chem, Pharming Group, Angion Biomedica, among others. Acute Kidney Injury Epidemiology Forecast Acute Kidney Injury Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted acute kidney injury epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key chronic kidney disease companies, including Bayer, AstraZeneca, Celgene, Ipsen, among others. Anemia in Chronic Kidney Disease Pipeline Anemia in Chronic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in chronic kidney disease companies, including Pieris Pharmaceuticals, Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, among others. Diabetic Kidney Disease Pipeline Diabetic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key diabetic kidney disease companies, including Gilead Sciences, Kyowa Kirin, Bayer, among others. Polycystic Kidney Disease Pipeline Polycystic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 22+ companies and 22+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in polycystic kidney disease companies, including Abbott, Reata Pharmaceuticals, XORTX Therapeutics, Sanofi Genzyme, among others. Kidney Transplant Rejection Pipeline Kidney Transplant Rejection Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in kidney transplant rejection companies, including Medeor Therapeutics, Talaris Therapeutics, CSL Behring, Novartis, among others. Other Trending Reports Pediatric Growth Hormone Deficiency Market | Non-Cystic Fibrosis Bronchiectasis Market | X-Linked Retinitis Pigmentosa Market | Otitis Media Market | Central Retinal Vein Occlusion Market | Frontotemporal Dementia Market | Follicular Lymphoma Market | Diabetes Market | Blastic Plasmacytoid Dendritic Cell Neoplasm Market | Bevacizumab Biosimilars Insight | Bacterial Conjunctivitis Market | FENEBRUTINIB Market | Peripherally Inserted Central Catheter Devices Market | Cardiac Biomarkers Testing Devices Market Related Healthcare Blogs Acute Kidney Injury Market Outlook Acute Kidney Injury Treatment Market IgA Nephropathy Market About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Biosimilar

21 Oct 2010

·www.biospace.com

Cerenis Therapeutics, Inc. Adds To Stockpile With Another $13.9 Million

TOULOUSE, France & ANN ARBOR, MI--(BUSINESS WIRE)-- Cerenis Therapeutics (Cerenis), a biopharmaceutical company specializing in the research and development of novel therapies based on HDL (“good” cholesterol) to treat cardiovascular and other metabolic diseases, announced today it has raised a further €10 million in a second close of its Series C financing. This takes the total funds raised in the Series C to €50 million and the total equity investment raised to date by the Company to €117 million. The latest €10 million came from the group IRDI-IXO (€2.5 million each) and undisclosed international private investors. These investors join an impressive shareholder base alongside first close new investor, Strategic Investment Fund (FSI), which invested €20 million, and all historic investors: Sofinnova Partners, HealthCap, Alta Partners, TVM Capital, EDF Ventures, OrbiMed and DAIWA Corporate Investment who invested the remaining €20 million. The first close was announced in July this year. Jean-Louis Dasseux, co-founder and CEO of Cerenis said: "We are delighted to close this additional Series C financing. Cerenis is now well positioned to continue its growth and HDL program development. ” This financing will fund Phase II development of the lead Cerenis program, CER-001, an HDL-mimetic for the treatment of cardiovascular disease; it will also support the development of other new HDL therapies. Overall, the investment supports Cerenis’ objective to bring major innovative breakthroughs to one of the main areas of need in human health. CER-001, Cerenis’ lead product, is being developed to rapidly regress atherosclerotic plaque, and is currently targeted for patients with Acute Coronary Syndrome. CER-001 has the potential to be the first and best in class recombinant HDL mimetic and a novel approach to treating cardiovascular disease and atherosclerosis, which remains the leading cause of death and morbidity worldwide. About Cerenis Cerenis Therapeutics is a pharmaceutical company focused on the discovery, development and commercialization of breakthrough HDL therapies for the treatment of cardiovascular and metabolic diseases. Based on pioneering research conducted by Cerenis' team of world leaders in HDL therapy, the company is pursuing a range of HDL product candidates that are positioned to represent major advances in patient care and significant commercial opportunities in the treatment of cardiovascular and metabolic diseases. Cerenis has raised over €117 million in venture financing and has operations in Toulouse, France and Ann Arbor, Michigan. For more information please visit: About IXO Private Equity and IRDI IXO Private Equity is a private equity firm managing FCPR and FIP and advises IRDI. IXO invests in Venture Capital, LBO and Capital Development. Founded 30 years ago and located in Toulouse, IXO is the most important French regional independent actor in private equity managing 300 m€. It invests from 0,5 m€ to 10 m€ by target company in the West and South of France.

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Pipeline Snapshot as of 25 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

CER-209 ( P2Y13 receptor )	Nonalcoholic Steatohepatitis More	Phase 1
CER-001 ( APOA1 x SCARB1 )	Familial HDL Deficiency More	Discontinued
Aspirin/Nicotinic Acid ( COX x HCAR3 x NIACR1 )	Dyslipidemias More	Discontinued
CER-522 ( APOA1 )	Aortic Valve Stenosis More	Discontinued
CER-227185 ( TCTP )	Acute Myeloid Leukemia More	Discontinued

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