AZD-0233

Plus, news about Eli Lilly and Cognition Therapeutics: 🔎 FDA simplifies REMS for Travere’s kidney drug: The updated safety strategy for Travere’s Filspari recommends liver monitoring once every three months, down from once a month. The FDA also removed the requirement for embryo-fetal toxicity monitoring. The changes are based on post-marketing surveillance data as well as results from various clinical studies, Travere said. Filspari secured full FDA approval for IgA neuropathy last year. — Ayisha Sharma 🛑 AstraZeneca halts Phase 1 cardio trial: The UK drugmaker has paused a healthy volunteer trial due to “an unexpected preclinical safety finding,” a spokesperson said in an emailed statement to Endpoints News on Wednesday. The pharma company is analyzing the safety findings to “determine next steps” for the in-house developed program known as AZD0233, the spokesperson added. One site is listed on the US federal trials database for the study of the oral treatment candidate. — Kyle LaHucik 👩🏻‍⚕️ Eli Lilly’s tirzepatide shows promise in type 1 diabetes : A retrospective academic trial looked at 57 patients with type 1 diabetes and obesity who were taking tirzepatide. The study found that the average amount of insulin the patients took in a day was cut by 23% at six months, and their average blood sugar levels decreased by 3.7 mmol/mol. The GLP-1/GIP agonist yielded weight loss of 9.3%. Patients’ time in the target blood sugar range increased by 7.3%, without any increases in hypoglycemia, which has been seen in previous studies of GLP-1 agonists in type 1 diabetes. The data came as an early release from the annual meeting of the European Association for the Study of Diabetes, to be held in Vienna, Austria, in mid-September. Lilly sells tirzepatide as Mounjaro for type 2 diabetes and Zepbound for obesity. — Elizabeth Cairns 💵 Cognition Therapeutics to raise $30M in direct offering: Proceeds from the share sale should help the company fund Phase 3 development of zervimesine in neurodegenerative disorders, among other activities. — Ayisha Sharma