All articles tagged with #phase 3 trial
Merck announced promising Phase 3 trial results showing that enlicitide decanoate, an investigational oral PCSK9 inhibitor, significantly reduces LDL cholesterol by over 55% with a safety profile similar to placebo, potentially offering a new oral treatment for cardiovascular disease prevention.
Moderna's experimental cytomegalovirus (CMV) vaccine failed in a Phase 3 trial, marking a significant setback for the company, which had high sales expectations for the vaccine prior to the failure amid ongoing pressures from Wall Street and the government.
aTyr Pharma's Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint of reducing corticosteroid dose at week 48, but secondary outcomes showed some benefits such as higher rates of steroid withdrawal and improved lung scores. The drug was well-tolerated, and the company plans to consult with the FDA to determine the next steps.
Eli Lilly's oral GLP-1 receptor agonist, orforglipron, successfully met primary and secondary endpoints in a Phase 3 trial, showing significant weight loss and A1C reduction in adults with obesity or overweight and type 2 diabetes, leading to plans for global regulatory submissions.
Bristol Myers Squibb plans to discuss FDA approval for Reblozyl in treating anemia despite a failed phase 3 trial that narrowly missed statistical significance, citing clinically meaningful benefits and future data sharing, amidst a year of clinical setbacks for the company.
Compass Pathways' Phase 3 trial of its synthetic psilocybin, COMP360, showed a significant separation from placebo in treating treatment-resistant depression, with no new safety concerns, marking a major milestone for psychedelic drug development. The company is now focusing on a larger, multi-dose trial expected to provide clearer efficacy data and aims for FDA submission, while preparing for potential U.S. market launch.
Akeso and Summit Therapeutics' drug ivonescimab showed promising results in delaying progression of certain lung cancers in a global phase 3 trial, with significant improvements in progression-free survival, though overall survival benefits are still being evaluated. The drug demonstrated consistent effects across Asian and Western populations, and the companies plan to seek FDA approval, despite some investor disappointment over the overall survival data.
Cassava Sciences has completed its Phase 3 RETHINK-ALZ trial for simufilam, an Alzheimer's treatment candidate, with topline data expected by the end of the year.
Summit Therapeutics' stock surged after the company announced that its cancer drug outperformed Keytruda in a Phase 3 trial, just ahead of a major cancer conference in Chicago.
Insmed's experimental drug brensocatib successfully reduced lung problems in bronchiectasis patients during a Phase 3 trial, leading to a significant increase in the company's share price. Both tested dosages of the drug met the primary endpoint by reducing pulmonary exacerbations by about 20% compared to placebo, with analysts predicting potential billion-dollar annual sales if approved.
Novo Nordisk's semaglutide significantly reduced the risk of major cardiovascular events and death in patients with type 2 diabetes and chronic kidney disease in a Phase 3 study, supporting its potential for broader indications. The results were presented at the European Renal Association's conference and published in the New England Journal of Medicine.
Moderna has reported positive interim results from the Phase 3 trial of its next-generation COVID-19 vaccine, mRNA-1283, showing a stronger immune response compared to its licensed COVID-19 vaccine, mRNA-1273.222. The new vaccine design offers potential storage advantages and paves the way for a combination vaccine against influenza and COVID-19. The trial demonstrated a higher immune response against both Omicron and original virus strains, particularly in participants over 65 years old. The vaccine's safety profile was found to be similar to Moderna's approved COVID-19 vaccines, and detailed trial data will be presented at upcoming events.
The inflammation-targeting therapy Dupixent, developed by Sanofi and Regeneron Pharmaceuticals, has shown success in a Phase 3 trial for patients with chronic lung disease COPD. If approved, it would be the first biologic treatment for COPD, potentially expanding the market for the blockbuster medicine.
Merck has announced positive Phase 3 trial results for WELIREG (belzutifan), its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in the treatment of advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. The trial showed statistically significant improvements in progression-free survival (PFS) compared to everolimus, as well as a significant improvement in objective response rate (ORR). While there was a trend towards improvement in overall survival (OS), it did not reach statistical significance. The safety profile of WELIREG was consistent with previous studies.
AstraZeneca's stock is declining as the company announced disappointing results from a Phase 3 trial of a lung-cancer drug.