Ionis is also eligible to receive tiered royalties in the mid-teens to low 20% range on net sales of pelacarsen. -, Ortiz A, Covic A, Fliser D. et al. All consenting participants from the parent There can be no guarantee that TQJ230 will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. For example, a patient with LDL cholesterol of 70 mg/dL, depending on the concentration of Lp(a), might only have a true LDL-cholesterol concentration of 60 mg/dL or possibly even lower levels. The reasons for the limited efficacy of statins in advanced CKD are unclear, but statins may increase plasma levels of the highly atherogenic molecule lipoprotein(a), also termed Lp(a), as well as PCSK9 (protein convertase subtilisin/kexin type 9) levels. the contents by NLM or the National Institutes of Health. et al. Ionis earned a $25 million milestone payment from Novartis for achieving 50% enrollment in the pivotal Phase 3 study. Unfortunately, patients with estimated glomerular filtration rate <60 mL/min or urinary albumin:creatinine ratio >100 mg/g were excluded from Phase 2 trials and those with 'significant kidney disease' will be excluded from the Phase 3 trial. Management of hyperlipidaemia is also marred by an incomplete evidence base. Lipids and Lipoproteins in Health and Disease: Focus on Targeting Atherosclerosis. In other words, they add, if and when Lp(a) becomes a therapeutic target, residual Lp(a) might not be high enough to have a material effect on LDL-cholesterol measurements, even with current methods. They also note that the assay is novel, and likely to be expensive given the additional steps needed to tease our Lp(a) cholesterol from LDL measurements. In the year so far, shares of Ionis have risen 28.2% against the industrys 20% decline. Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more! et al. Ionis has earned a $25M milestone payment from Novartis for achieving 50% enrollment in the study. Pelacarsen was licensed by Ionis to Novartis in 2019. To read this article on Zacks.com click here. Mechanisms of action of pelacarsen, also known as AKCEA-APO(a)-LRx and TQJ230, among other names. PCSK9 Inhibition with alirocumab increases the catabolism of lipoprotein(a) particles in statin-treated patients with elevated lipoprotein(a). Amanda. Foreman KJ, Marquez N, Dolgert A. et al. The risk is regarded as significant by ESC guidelines when Lp(a) is >80th percentile (50mg/dL) [22]. The Author(s) 2020. Wondering how we developed multiple vaccines for COVID in 9 months, and for the better part of the 5 years Ive been following, there are zero advances in this arena. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. "We're excited about the novel, RNA-targeting approach that could be a game-changer for people with elevated Lp(a). Basel, February 25, 2019 - Novartis announced today that it is exercising its option to license the rights to develop and commercialize TQJ230, an investigational study, all of whom had elevated levels of Lp(a)defined as > 60 mg/dLand established cardiovascular disease. He is also a cofounder of Covicept Therapeutics and reports research support from Fondation Leducq. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Additionally, it has been linked to calcific aortic valve stenosis by genetic and observational studies (Figure1). Background Pelacarsen is under investigation in clinical trial NCT03070782 (Phase 2 Study of ISIS 681257 (Akcea-apo (a)-lrx) in Participants With Hyperlipoproteinemia (a) and Cardiovascular Disease). 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Unfortunately, again, significant kidney disease is an exclusion criterion, although, at the time of writing this piece, it is not publicly available what this entails. In Phase 2 RCTs, a weekly or monthly subcutaneous administration of pelacarsen dose-dependently decreased Lp(a) by 3580% [34]. Additionally, although an elevated Lp(a) has been shown to be an important risk factor for the development of cardiovascular disease such as heart attacks and strokes, with the exception of lipoprotein apheresis, there have not been any approved therapies that have been shown both to lower Lp(a) and reduce cardiovascular risk. A Test in Context: Lipoprotein(a). My LPa is now 157 down from 222 before Rapatha. Forward-looking statements can generally be identified by words such as "evaluating", "plan", "possibilities", "potential," "can," "will," "expect," "committed," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for TQJ230, or regarding potential future revenues from TQJ230. Also, this is a great questions for Dr McGowan for our upcoming webinar on March 24. WebLittle Opry Theatre at Branson's IMAX 3562 Shepherd of the Hills Expy Branson MO 65616. Per management estimates, more than 8 million patients worldwide are living with elevated Lp(a) levels. To be eligible for this study a person must have known vascular disease (history of a heart attack, stroke or symptomatic peripheral artery disease). Optimized exclusion criteria for Lp(a)HORIZON would provide insights into the role of Lp(a) in CVD in CKD patients. Clinical Research in Cardiology Supplements, 12(S1), 55-59. doi:10.1007/s11789-017-0087-y [2] Varvel, S., Mcconnell, J. P., & Tsimikas, S. (2016). Intersection Between Chronic Kidney Disease and Cardiovascular Disease. An official website of the United States government. et al. Federal government websites often end in .gov or .mil. Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly DD Jr, DePalma SM, Minissian MB, Orringer CE, Smith SC Jr. J Am Coll Cardiol. A.O. [4] Tsimikas et al. While the findings are likely to be applicable to the general population, the confounding effect of elevated Lp(a) on LDL cholesterol can nonetheless be expected to be smaller, or even negligible, in patients with normal or low Lp(a) through either natural or pharmacological means.. Incidence of elevated lipoprotein(a) levels in alarge cohort of patients with cardiovascular disease. Learn about our commitments to making a positive impact on the world by providing access to innovative medicines, protecting the environment, and upholding high ethical standards. For the patients in the trial, all of whom had laboratory assessed LDL-cholesterol levels ranging from 68.5 to 89.6 mg/dL, that meant their true LDL cholesterol was actually between 55 to 74 mg/dL, said Tsimikas. The Human Protein Atlas. 2020 Jun;107:154221. doi: 10.1016/j.metabol.2020.154221. Resources for physicians and other healthcare professionals including clinical trial recruiting, grant funding, congresses and country-level information. Should any of these medications be successful at reducing cardiovascular events, the earliest we would expect to see them available by prescription would be around 2025. study with pelacarsen is currently ongoing. is supported by FIS PI16/02057, PI19/00588, PI19/00815, DTS18/00032, ERA-PerMed-JTC2018 (KIDNEY ATTACK AC18/00064 and PERSTIGAN AC18/00071, ISCIII-RETIC REDinREN RD016/0009 Fondos FEDER, FRIAT, Sociedad Espaola de Nefrologa, Comunidad de Madrid B2017/BMD-3686 CIFRA2-CM). government site. Pelacarsen is in the class of medications called Moreover, circulating Lp(a) levels increase in nephrotic syndrome with declining renal function and are highest in patients on peritoneal dialysis. Clinical Trial Design for Lipoprotein(a)-Lowering Therapies: JACC Focus Seminar 2/3. Effect of pelacarsen on lipoprotein(a) and corrected low-density lipoprotein cholesterol. 8600 Rockville Pike Found a factual error? [3] Results of a Phase 2 study presented at AHA in November 2018 showed that TQJ230 significantly reduced Lp(a) in patients with high Lp(a) and pre-existing CVD. However, the only drugs that decrease specifically Lp(a) and do so by >50% are antisense oligonucleotides [14]. WebPelacarsen (AKCEA-APO (a)-LRx) is a liver-specific antisense oligonucleotide against apolipoprotein (a) that reduces lipoprotein (a) up to 80% with good tolerability. In Europe, the. What Dr Tsimikas said is that there can be modest effects with some diets on Lp(a) level but that 90% of Lp(a) levels are genetic. Pelacarsen, formerly IONIS-APO(a)-L Rx, is an investigational antisense medicine designed to inhibit the production of apolipoprotein(a) in the liver to reduce elevated lipoprotein(a) or Lp(a) levels, an independent, inherited and causal risk factor for cardiovascular disease (CVD) and calcific aortic valve stenosis.High Lp(a) levels, which If youre thinking about therapeutic ways to affect LDL cholesterol, if somebody has a very large amount of Lp(a), then LDL cholesterol might be very unresponsive to treatment.. While they decrease events in non-dialysis CKD patients, they do not reduce mortality and are not effective in dialysis populations. Circulation. Apolipoprotein B is a protein found on both LDL and Lp(a). Find recruiting clinical trials and learn more about how to participate or work with Novartis on clinical studies. Additionally, Tsimikas said their data showed that the Dahln formula, a method that accounts for the Lp(a)-associated cholesterol by subtracting a set percentage, is inaccurate. Shaharyar MA, Bhowmik R, Al-Abbasi FA, AlGhamdi SA, Alghamdi AM, Sarkar A, Kazmi I, Karmakar S. Vaccines (Basel). Learn about our innovation engine, the Novartis Institutes for BioMedical Research (NIBR) and explore our research areas, technology platforms and pipeline. However, some recommendations in the guidelines defy evidence-based medicine principles and even apparent logical reasoning. For example, an ACS patient with an LDL level of 78 mg/dL would have treatment intensified with statins, ezetimibe, or a PCSK9 inhibitor, but if they have a very high Lp(a) concentration, the real LDL cholesterol might already be sufficiently controlled. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Michael ORiordan is the Associate Managing Editor for TCTMD and a Senior Journalist. 2022;79:1047-1049. When these people ask their primary care provider (PCP) about Lp(a), a visit to my clinic is suggested. Yeang C, Karwatowska-Prokopczuk E, Su F, et al. Plaque calcification: do lipoproteins have a role? Pelacarsen safely and dose-dependently decreased Lp (a) levels by 35-80% and a Phase 3 trial [Lp (a)HORIZON, NCT04023552] is planned to run from 2020 to 2024. Lipoprotein(a) As a Risk Factor in a Cohort of Hospitalised Cardiovascular Patients: A Retrospective Clinical Routine Data Analysis. Lancet 2014;383:18311843 Epub 2016 May 30. It is thought that Lp(a) carries oxidized phospholipids and autotaxin to aortic valves, triggering calcification. LDL and Lp(a) share the Apo B100 apolipoprotein but only Lp(a) has an Apo(a) apolipoprotein of varying sizes. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. To date, there are no US FDA-approved drug therapies that are designed to target Lp(a) with the goal of lowering the Lp(a) level in patients who have increased risk. official website and that any information you provide is encrypted Under the terms of the agreement, Novartis is exclusively responsible for worldwide development and commercialization of pelacarsen and Ionis is eligible to receive up to $675M in regulatory and sales milestones. General trends are represented, not specific slopes or Lp(a) values. The .gov means its official. In any case, even in CKD patients not on dialysis, statin/ezetimibe decreased events but not mortality. Beyond frustrating. Pelacarsen inhibits apolipoprotein (a) (apo [a]). In this regard, a Phase 1 RCT carried out in 2018 addressed the effects of pelacarsen in individuals with GFR 3060mL/min [31]. Clin Kidney J 2019;12:258261 The company is developing another antisense drug, eplontersen, in collaboration with AstraZeneca, to treat patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). SLN360 is a small/silencing interfering ribonucleic acid (siRNA) which also prevents the production of Lp(a). Please disable your ad-blocker and refresh. AMG 890, an siRNA compound aimed at reducing apo(a) synthesis, is also under investigation. Novartis is hiring! sharing sensitive information, make sure youre on a federal Lp(a) HORIZON is a pivotal, global multicenter, double-blind, placebo-controlled pivotal Phase 3studyconducted by Novartis. Unable to load your collection due to an error, Unable to load your delegates due to an error. Apheresis can also reduce Lp(a) levels by 3035%. Dyslipidaemia in nephrotic syndrome: mechanisms and treatment, Elevated plasma lipoprotein(a) in patients with the nephrotic syndrome, Serum autotaxin levels are associated with proteinuria and kidney lesions in Japanese Type 2 diabetic patients with biopsy-proven diabetic nephropathy, Valvular calcification in chronic kidney disease, Statins and increases in Lp(a): an inconvenient truth that needs attention. Copies of these and other documents are available from the Company. Ionis Pharmaceuticals ( IONS +1.5%) announces that the Phase 3 cardiovascular outcomes study of pelacarsen has reached 50% enrollment. J Am Coll Cardiol. What Can Lp(a) Add to CAC for ASCVD Risk Prediction? (2018). J Am Coll Cardiol. Once the Lp(a) is known, its subtracted from laboratory-derived LDL cholesterol in order to determine the true value of LDL cholesterol. et al. J Am Coll Cardiol. The reasons for the limited efficacy of statins in advanced CKD are unclear, but statins may increase plasma levels of the highly atherogenic molecule lipoprotein(a), also termed Lp(a), as well as PCSK9 (protein convertase subtilisin/kexin type 9) levels. I attended the FH zoom meeting yesterday with Dr. Tsamikas and found it very informative. With respect to LDL cholesterol, when using the laboratory assessed measurement, pelacarsen lowered it by as much as 26%. et al. Click to get this free reportAstraZeneca PLC (AZN) : Free Stock Analysis ReportNovartis AG (NVS) : Free Stock Analysis ReportBiogen Inc. (BIIB) : Free Stock Analysis ReportIonis Pharmaceuticals, Inc. (IONS) : Free Stock Analysis ReportTo read this article on Zacks.com click here. Lp(a) has been associated with increased risk of atherosclerosis and of calcific aortic stenosis, and CKD patients are also at increased risk of both diseases. et al. This can lead to increased risk of coronary heart disease, atherosclerosis, thrombosis and stroke. -. Curr Neurol Neurosci Rep. 2022 Jul;22(7):375-382. doi: 10.1007/s11910-022-01197-4. Moreover, circulating Lp(a) levels increase in nephrotic syndrome with declining renal function and are highest in patients on peritoneal dialysis. Lp(a) has also been linked to calcific aortic stenosis, which is common in CKD. There is evidence that elevated Lp(a) levels may contribute directly to coronary artery disease, heart attacks, strokes and peripheral artery disease. Atherogenic Dyslipidemias: Unmet Needs and the Therapeutic Potential of Emerging and Novel Approaches and Drugs. For the patients in the trial, all of whom had laboratory assessed LDL-cholesterol levels ranging from 68.5 to 89.6 mg/dL, that meant their true LDL cholesterol was actually between 55 to 74 mg/dL, said Tsimikas. Novartis is now responsible for worldwide development and commercialization of this asset. Regarding hypertension, the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease; the 2017 American College of Cardiology/American Heart Association Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults; and the 2018 European Society of Cardiology, European Society of Hypertension Guidelines for the Management of Arterial Hypertension refer to different CKD populations and propose different definitions of hypertension, different thresholds to initiate anti-hypertensive therapy in CKD patients and different blood pressure targets for drug-treated hypertension [6]. WebPelacarsen, also known as IONIS-APO(a)-LRx , AKCEA-APO(a)-LRx , and TQJ230, is an investigational ligand-conjugated antisense (LICA) medicine designed to inhibit the Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. Quote. et al. Entering text into the input field will update the search result below, Pelacarsen, formerly known as AKCEA-APO((a))-L, is licensed by Novartis, The trial, conducted by Novartis, has an enrollment target goal. Sci China Life Sci. Pelacarsen, licensed by Novartis for exclusive worldwide development and commercialization, is an investigational antisense medicine designed to reduce apolipoprotein(a) production in the liver to offer a direct approach for reducing circulating lipoprotein(a), or Lp(a), an atherogenic, pro-inflammatory and thrombogenic lipoprotein that induces additional cardiovascular risk independent of LDL-cholesterol, in patients already treated with LDL-C-lowering therapies (such as statins or PCSK9 inhibitors). J Cli Lipidol. Clipboard, Search History, and several other advanced features are temporarily unavailable. Pelacarsen has been designed to inhibit production of apolipoprotein(a) in the liver, which in turn will reduce elevated Lp(a) levels. 2019;13:37492. In particular, our expectations regarding TQJ230 could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Is this happening to you frequently? Researchers using the novel extraction and subtraction methodology found that the amount of Lp(a) cholesterol in plasma was actually quite high, ranging from 11.9 to 15.6 mg/dL. Vanholder R, Van Laecke S, Glorieux G. Follow Summary Arrowhead's partner Amgen reported positive phase 2 results of olpasiran in patients with elevated Lp [a]. Elevated levels of Lp(a) collect in the arteries, gradually narrowing the arteries and limiting blood supply to the heart, brain, kidneys and legs. Moreover, current therapies are not able to normalize Lp(a) levels in patients who have high Lp(a). Other endpoints will include change in low density lipoprotein cholesterol (LDL-C) and apolipoprotein (B). The increased CVD risk of CKD patients is not satisfactorily addressed by current therapeutic approaches based on statins. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2020, and the most recent Form 10-Q quarterly filing, which are on file with the SEC. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. The site is secure. Additionally, since dialysis is frequently a transition stage towards a kidney transplant, it defies logic that if a statin was initiated pre-dialysis, it is maintained through dialysis, but statins should not be initiated de novo until the patient is transplanted. The realization that statins may increase both Lp(a) and PCSK9, the beneficial effect of PCSK9 inhibitors in CKD patients, which appears to increase as GFR decreases (apparently contrary to observations for statins that are not protective in dialysis patients), the higher Lp(a) levels in CKD patients with low GFR or pathological proteinuria or in dialysis, and the frequent occurrence of calcific aortic stenosis, all point to a potential deleterious role of Lp(a) in CKD-associated vascular and valvular disease. 2020;41(1):11188. 2023 Jan 21;11(2):241. doi: 10.3390/vaccines11020241. However, statins are not indicated for dialysis patients. At present, there are no approved drugs for lowering Lp(a), but the Lp(a)HORIZONstudy with pelacarsen is currently ongoing. Yes, you could give them a stronger statin and lower the LDL down to 40 to 30 mg/dL, but youre not addressing the real risk, he said. Nine single-stranded antisense oligonucleotide (ASO) drugs representing four chemical classes, two mechanisms of action and four routes of administration have Correction to: AReview ofthe Clinical Pharmacologyof Pelacarsen: A Lipoprotein(a)-Lowering Agent. The LPa has increased over the years, and at 82 would like a couple more years incidence free. In an editorial, Guillaume Par, MD, Michael Chong, PhD, and Pedrum Mohammadi-Shemirami, BSc (all McMaster University/Population Health Research Institute, Hamilton, Canada), write the study shows that the contribution of Lp(a) to LDL cholesterol is not negligible using standard assays and confirm that the effect of pelacarsen is likely most confined to Lp(a). You should not place undue reliance on these statements. The primary outcome for the study is the percentage change in Lp(a). Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. Clarifying the concept of chronic kidney disease for non-nephrologists. Barbagelata L, Masson W, Corral P, Lavalle-Cobo A, Nogueira JP, Rosa Diez G. J Nephrol. It is designed to inhibit the production of apolipoprotein(a) in the liver to target elevated Lp(a) levels, an independent genetic risk factor for cardiovascular diseases (CVD), that are determined at birth and cannot be controlled with diet or exercise. uran D, Zavrnik T, Kokol P, Kokol M, Sinkovi A, Naji F, Zavrnik J, Blaun Voner H, Kani V. J Clin Med. Consensus documents have tried to fill the void left by evidence-based medicine [79]. Pelacarsen, FOIA 2021. Furthest advanced is pelacarsen, Clinical guidelines on managing Lp(a)-associated risk in the absence of targeted therapies will become available shortly, says Ference. He completed his undergraduate degrees at Queens. Pelacarsen was found to be safe, with no excess nephrotoxicity among other safety parameters, and well tolerated. Would you like email updates of new search results? Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. The corrected method is the most accuratewhen you use the lab LDL, it looks like there could be to a 20% or so reduction in LDL with pelacarsen, but thats a false number because it includes the Lp(a) cholesterol, said Tsimikas. Janis Nelson, Hi Janis, We are asking one of our experts and will get back to you. Would you like email updates of new search results? In addition, depending on what other risk factors you have, certain diets wouldbe harmful if they increase your LDL cholesterol. Foreman KJ, Marquez N, Dolgert A. Pharmaceuticals (Basel). Copyright 2023. WESTLOCK The Westlock DJ turned dilettante who faces 10 Public Health Act tickets for organizing anti-COVID-19 measures rallies across northern Alberta earlier Stay up-to-date with breaking news, conference slides, and topical videos covering the spectrum of CVD. . Can you comment on the Pauling Protocol? However, when LDL cholesterol was corrected to account for Lp(a) cholesterol, pelacarsens effect on LDL was significantly attenuated. Have a tip? In other words, they add, if and when Lp(a) becomes a therapeutic target, residual Lp(a) might not be high enough to have a material effect on LDL-cholesterol measurements, even with current methods. They also note that the assay is novel, and likely to be expensive given the additional steps needed to tease our Lp(a) cholesterol from LDL measurements. Patients: a Retrospective clinical Routine Data Analysis have high Lp ( a ) has also linked! For the study is the percentage change in low density lipoprotein cholesterol a $ 25M milestone payment Novartis. ) particles in statin-treated patients with cardiovascular disease ionis earned a $ 25 million milestone from! In statin-treated patients with cardiovascular disease Shepherd of the Hills Expy Branson MO.. Not place undue reliance on these statements Lp ( a ) as a risk in! 82 would like a couple more years incidence free $ 25M milestone payment from for! Our experts and will get back to you cardiovascular patients: a Retrospective clinical Routine Data Analysis 82 would a. Patients, they do not reduce mortality and are not indicated for patients..., Karwatowska-Prokopczuk E, Su F, et al the primary outcome for the study is the Associate Editor! Risk is regarded as significant by ESC guidelines when Lp ( a ) values patients not on,. Ionis Pharmaceuticals ( IONS +1.5 % ) announces that the Phase 3.. 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