- ION449 (AZD8233) met phase primary endpoint 2b Solano Studies for patients with hypercholesterolemia
- ION449 will not proceed to Phase 3 development based on pre-specified criteria
carlsbad, california, September 23, 2022 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: ion) announced today the topline results of the phase 2b Solano In a study in hypercholesterolemic patients, monthly ION449 (AZD8233) 60 mg was statistically significantly associated with low-density lipoprotein cholesterol (LDL-C) levels of 62.3% after 28 weeks compared to placebo (p<0.001), demonstrating that it met the primary criteria of the study. Validity endpoint. ION449 was generally safe and well tolerated in this study. However, these results did not meet pre-specified efficacy criteria, and AstraZeneca decided not to proceed with her ION449 (AZD8233) into Phase 3 development in hypercholesterolemia. AstraZeneca continues to analyze trial results. Solano Investigate to determine next steps for the program.
“While the LDL-C reductions seen in high-risk hypercholesterolemic patients receiving maximal statin therapy were statistically significant and conclusive, these results are not the It did not meet the criteria of AstraZeneca’s Target Product Profile to invest in the three-phase development program.” Eugene Schneider, MD, Executive Vice President and Chief Clinical Development Officer of Ionis. “AstraZeneca continues to be a valuable collaborator and we look forward to working together to advance several important programs.”
about Solano
Solano (NCT04964557) was a randomized, parallel, double-blind, placebo-controlled phase 2b A study of 411 participants with hyperlipidemic LDL-C ≥70 mg/dL and maximally tolerated statin and/or ezetimibe <190 mg/dL. The primary objective of this trial was to evaluate the efficacy, safety and tolerability of ION449 (AZD8233) compared to placebo.
About ION449
ION449 (AZD8233) is a once-monthly subcutaneous investigational drug using Ionis’ advanced technology LiGundC.conjugated antisense (LICA) technology platform. It is designed to reduce plasma levels of the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is fully involved in the regulation of LDL cholesterol. Genetic studies have shown that people with a lifetime reduction in LDL-C due to PCSK9 dysfunction have a significantly reduced risk of cardiovascular disease. Pharmacological inhibition of PCSK9 significantly lowers LDL-C. ION449 is designed to reduce her production of PCSK9 in the liver, lower plasma levels of LDL-C, and reduce the risk of cardiovascular disease. AstraZeneca licensed his ION449 from Ionis in 2015.
About hypercholesterolemia
Hypercholesterolemia, or elevated levels of LDL-C in the blood, are important risk factors for cardiovascular disease, a leading cause of death worldwide. Despite taking high-intensity statins, approximately 50% of patients do not meet their treatment goals, and secondary prevention patients have significant unmet medical implications for more intensive LDL-C lowering therapy. I have a need. It is estimated that her 1 in 6 patients with LDL-C greater than her 100 mg/dL will suffer her second major adverse cardiovascular event in about 3 years.
About Ionis Pharmaceuticals
For more than 30 years, Ionis has been the leader in RNA-targeted therapies, opening new markets and changing the standard of care with its novel antisense technology. Ionis currently has three launched medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues today with the knowledge that sick people depend on us. This supports our vision of becoming a fully integrated, cutting-edge biotechnology company.
For more information on Ionis, please visit: www.ionispharma.com Follow us on Twitter @ionispharma.
Ionis Forward-Looking Statement
This press release contains forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of Ionis’ technology, ION449 and other products in development. Statements describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs are forward-looking statements and should be considered risky statements. Such statements relate to the potential impact of COVID-19 on our business and to our commercial products and pipeline medicines, particularly their use as human therapeutics. the process of discovering, developing and commercializing safe and effective medicines, and efforts to build businesses around such medicines. Ionis’ forward-looking statements contain statements that, if they do not materialize or prove correct, our results could differ materially from those expressed or implied by such forward-looking statements. It also includes the assumption that
Ionis’ forward-looking statements reflect the good faith judgment of management, but these statements are based solely on facts and factors currently known to Ionis. Therefore, you are cautioned not to rely on these forward-looking statements. These and other risks related to Ionis’ programs are detailed in his Ionis annual report on Form 10-K for the closing year. December 31, 2021, and the latest Form 10-Q quarterly filings filed with the U.S. Securities and Exchange Commission. Copies of these and other documents are available from us.
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