PCSK9

NEW YORK, Sept. 25, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Verve Therapeutics, Inc. ("Verve" or the "Company") (NASDAQ: VERV). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. The class action concerns whether Verve and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. You have until October 28, 2024, to ask the Court to appoint you as Lead Plaintiff for the class if you are a shareholder who purchased or otherwise acquired Verve securities during the Class Period. A copy of the Complaint can be obtained a t . [Click here for information about joining the class action] On April 2, 2024, Verve Therapeutics issued a press release entitled "Verve Therapeutics Announces Updates on its PCSK9 Program." The press release disclosed that the Company was halting enrollment in the Heart-1 clinical trial of VERVE-101 as a treatment for patients with heterozygous familial hypercholesterolemia (HeFH). Verve cited an adverse event in an individual who had been dosed at 0.45 mg/kg of VERVE-101, stating that "at potentially therapeutic dose levels of VERVE-101, we have observed certain asymptomatic laboratory abnormalities, which we believe are attributable to the [lipid nanoparticle] delivery system." On this news, Verve's stock price fell $4.47 per share, or 34.95%, to close at $8.32 per share on April 2, 2024. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Participants in front of the logo of the European Society of Cardiology at a previous meeting. The 2024 conference was held in London 30 August-2 September. Image credit: Shutterstock/hydebrink The results of two subanalyses of the PACMAN-AMI trial were presented on the final day (2 September) of the European Society of Cardiology (ESC) 2024 Congress. Coronary heart disease is the most frequent cause of mortality in the industrialised world, and hypercholesterolaemia is a major risk factor. Statins are the first-line therapy, but are often not wholly effective. Several studies have demonstrated low-density lipoprotein cholesterol (LDL-C) reduction with PCSK9 inhibition, in addition to decreased adverse cardiovascular events. The Phase III PACMAN-AMI trial (NCT03067844) investigated the effect of Regeneron Pharmaceutials’ PCSK9 inhibitor Praluent (alirocumab), a PCSK9 inhibitor, in patients with acute myocardial infarction (AMI). Some data from the study was presented earlier at the conference during a session outlining the efficacy of antibodies like Praluent in reducing LDL-C levels . In the study, patients received Praluent or placebo every two weeks alongside statin therapy. After 52 weeks, PCSK9 inhibition significantly reduced percent atheroma volume (PAV), the difference between vessel and lumen volumes, and other measures of blood vessel occlusion compared to statin therapy alone. See Also: Novavax wins FDA emergency approval for updated Covid-19 vaccine Global Calcium hit with Form 483 after Indian factory inspection Subanalyses provide more insights Dr. Yasushi Ueki from Shinshu University Hospital in Japan first presented a subanalysis of the PACMAN-AMI trial. His team used risk stratification to identify patients with the greatest potential for benefit from plaque regression. Ueki explained his group divided patients into three groups based on risk factors for chronic coronary disease—those with none, with one, or with two or more major risk factors. Blood vessel imaging for these patients was compared before and after 52 weeks of Praluent treatment or placebo between risk-stratified groups. Ueki’s team found PAV was only significantly reduced among patients with one or no risk factors, with, “no significant difference between patients with two or more risk factors”. This was also true regarding changes in maximum lipid core burden index and macrophage angle. According to Ueki, “among AMI patients with no or one atherothrombotic risk factors, the addition of alirocumab to high-intensity statin demonstrated greater coronary plaque regression; patients with fewer risk factors thus appear to be more susceptible for atheroma regression”. Dr. Flavio Biccirè from the University Hospital of Bern in Switzerland then spoke about his team’s subanalysis. They focused on vessel lesions, regions at which plaque buildup is most pronounced, as opposed to the PACMAN-AMI trial’s wider, vessel-level analysis. Identifying vessel lesions using imaging data from 245 patients, Biccirè and his colleagues remeasured clinical outcomes. They found that at the lesion level, PAV change with Praluent at 52 weeks was -4.9 compared to placebo, far greater than the -2.1 change stated in the original analysis. Biccirè concluded, “LDL-C lowering induced an extensive atheroma burden reduction at lesion-level”, and that, “significant changes in coronary lesions, rather than mild effects described at vessel-level, underlie the protective vascular effects of contemporary lipid-lowering therapies”.

New NHP data indicate robust silencing at clinically relevant dose levels and highlight potential best-in-class potency achievable with Chroma's epigenetic editors Chroma's epigenetic editor achieved efficient and durable reductions in blood PCSK9 (84%) and LDL-cholesterol (68%) following a single 1.0 mg/kg dose Potential for life-long durability supported by mechanistic data confirming robust and stable CpG methylation at the PCSK9 locus in NHPs BOSTON, Sept. 3, 2024 /PRNewswire/ -- Chroma Medicine, Inc., (Chroma) a genomic medicine company pioneering single-course epigenetic editing therapeutics, presented new preclinical data demonstrating the potency, durability, and specificity of its PCSK9-targeted epigenetic editor in an oral presentation at the 2024 European Society of Cardiology Congress, held August 30-September 2 in London. The data showcase the potential best-in-class potency achievable in NHPs with Chroma's optimized epigenetic editors. They also indicate the company's epigenetic editing platform can effectively silence expression of PCSK9 in the liver, inducing durable reductions in low-density lipoprotein-cholesterol (LDL-C) levels without cutting or nicking the DNA. The PCSK9 gene actively promotes the degradation of LDL receptors, thereby reducing the ability of the liver to clear cholesterol from the blood. This can result in chronically elevated blood levels of LDL-C and lead to increased risk for early onset atherosclerotic cardiovascular disease (ASCVD). Genetic and pharmacologic reductions in PCSK9 levels have been shown to correlate with decreased cardiovascular events, making it an established and compelling target for prevention of ASCVD. "These results underscore the successful optimization and development of a highly potent, durable, and specific PCSK9-targeted therapeutic," said Catherine Stehman-Breen, M.D., Chroma's Chief Executive Officer. "By demonstrating potency at clinically relevant doses, we have achieved a key requirement for successful translation of a lipid nanoparticle-delivered genomic medicine into an efficacious and well-tolerated therapeutic, supporting continued advancement toward clinical studies." Data from the presentation demonstrate best-in-class potency, with Chroma's human PCSK9-targeting epigenetic editor reaching saturating pharmacology at 1.0 mg/kg in NHPs. A significant reduction in circulating PCSK9 (84%) levels was achieved, resulting in a 68% reduction in LDL-C levels, maintained out to three months. Additional data show that the company's epigenetic editor efficiently and durably reduced PCSK9 levels in vivo for one year after a single administration in human transgenic mice. The silencing was maintained in mice pre- and post-partial hepatectomy, the standard surgical model for induction of liver regeneration. "We believe single-course therapies are crucial in the creation of genomic medicines that can disrupt the current treatment paradigm for lowering LDL-cholesterol and reduce the risk of serious cardiovascular disease," said Jenny Marlowe, Ph.D., Chroma's Chief Development Officer. "These data presented at ESC confirm the potential of our epigenetic editing platform to produce a highly potent therapeutic that can bring the promise of better treatment options within reach." Find the presentation on the Chroma website here. About ASCVD Chronically elevated blood levels of low-density lipoprotein-cholesterol (LDL-C) can lead to increased risk for early onset atherosclerotic cardiovascular disease (ASCVD), heart attack, and stroke. ASCVD is the leading cause of death in the United States and globally. Current therapeutic interventions often fail to lower LDL-C below designated therapeutic thresholds and require frequent dosing, leading to treatment adherence challenges. The PCSK9 gene actively promotes the degradation of LDL receptors, which are responsible for clearing LDL-C from the blood, thereby reducing the ability of the liver to clear cholesterol from the blood. Genetic and pharmacologic reductions in PCSK9 have been associated with decreased LDL-C levels and reduced risk for cardiovascular events. Chroma is advancing an in vivo epigenetic editing therapeutic designed to effectively and durably silence the PCSK9 gene without cutting or nicking the DNA, resulting in decreased PCSK9 protein levels and leading to lower LDL-C levels and reduced risk of ASCVD. About Chroma Medicine Chroma Medicine is a biotechnology company pioneering a new class of genomic medicines that harness epigenetics, nature's innate mechanism for gene regulation, to deliver precise, programmable single-course therapeutics while preserving genomic integrity. The company's modular platform enables development of medicines that can address a wide range of complex diseases, whether they require silencing, activation, or targeting multiple genes at once. Chroma was founded by the world's foremost experts in genomic research and is led by a veteran team of industry leaders and scientists with deep experience in genomic medicine, drug discovery, and development. For more information, please visit chromamedicine.com or follow us on LinkedIn and X. SOURCE Chroma Medicine