Semaglutide, Novo Nordisk's glucagon-like peptide 1 (GLP-1) receptor agonist, is showing promise in treating kidney disease, according to data presented at Kidney Week 2024. Researchers highlighted multiple clinical studies indicating that semaglutide improved kidney function in overweight or obese patients with albuminuric chronic kidney disease, even in the absence of diabetes. The Phase III Flow trial data, assessing semaglutide's effects on kidneys, was also a key focus of the conference.
GLP-1 Access and Future Trends
Despite the enthusiasm for GLP-1 drugs in treating obesity, significant obstacles hinder patient access. At the BioFuture 2024 conference in New York, a panel discussed the future of GLP-1s, noting that while 80% of the U.S. population is eligible for these therapies, high prices and limited insurance coverage pose major challenges. The panel predicted substantial changes in GLP-1 prescription and usage over the next five years, driven by broader insurance coverage and a considerable decrease in cost.
Glycomimetics' Acquisition and Uproleselan Trial
Glycomimetics Inc. experienced a surge in its stock price following an acquisition agreement with Crescent Biopharma Inc., a privately held company focused on solid tumors. A syndicate of investors has committed $200 million to acquire Glycomimetics' common stock and prefunded warrants. However, the company also announced that the Phase II analysis of uproleselan, in combination with chemotherapy, did not show a statistically significant improvement in event-free survival for adults with newly diagnosed acute myeloid leukemia who are 60 or older and fit for intensive chemotherapy. The study was conducted by the U.S. National Cancer Institute and the Alliance for Clinical Trials in Oncology.
Coya Therapeutics' Alzheimer's Data
Coya Therapeutics Inc. reported Phase II results for its low-dose IL-2 and CTLA4-Ig combination drug, COYA-301, in Alzheimer's disease patients. While dosing every four weeks showed promise, more frequent dosing every two weeks led to exhausted regulatory T cells (Tregs) and no benefits. The trial, which dosed patients for five days every four weeks or every two weeks with COYA-301 or placebo over a 21-week treatment period, demonstrated safety and tolerability with the less frequent dosing regimen. This resulted in a significant expansion of Treg populations without off-target effects, improved cerebrospinal fluid-soluble Aβ42 levels, and stabilized cognitive function.
Lexicon's Zynquista for Type 1 Diabetes
Lexicon Pharmaceuticals Inc. awaits the U.S. FDA's Endocrinologic and Metabolic Drugs Advisory Committee meeting regarding Zynquista (sotagliflozin), a proposed adjunct to insulin for improving glycemic control in people with type 1 diabetes (T1D) and chronic kidney disease. If approved, the dual SGLT-1, 2 inhibitor would be the only oral adjunct to insulin in this space. However, the FDA's briefing document raises questions about the evidence and uncertainties surrounding the molecule's effectiveness, benefit to patients, and its risks.
Astellas Withdraws Geographic Atrophy Application
Astellas Pharma Inc. has withdrawn its marketing authorization application from the EMA for its avacincaptad pegol intravitreal solution for the treatment of geographic atrophy secondary to age-related macular degeneration.
