While there is tremendous enthusiasm for GLP-1 drugs for use in obesity and 80% of the U.S. population is eligible to use the therapies, tremendous obstacles continue to block their access. The blockages include high prices that consumers currently cannot afford coupled with employer health plans that don’t offer the new treatments. A panel discussing the future of GLP-1s at the BioFuture 2024 conference in New York said the next five years will see enormous changes in the way these drugs are prescribed by physicians and used by patients. These changes, the panel said, will be driven by wider insurance coverage and a dramatic drop in cost.

Kidney Week 2024: Semaglutide tackles another organ

Semaglutide, the glucagon-like peptide 1 receptor agonist from Novo Nordisk that seemingly improves almost every disease, was a focus at Kidney Week 2024, where researchers presented data from multiple clinical studies in patients with kidney diseases. The drug improved kidney function in patients who were overweight or obese and had albuminuric chronic kidney disease without diabetes. There were also multiple presentations at the conference of different aspects of data from the phase III Flow trial testing the effects of semaglutide on kidneys.

Glycomimetics stock jumps on word of Crescent merger

Shares of Glycomimetics Inc. (NASDAQ:GLYC) were trading at 47 cents, up 30 cents, or 181%, as Wall Street heard of an acquisition agreement with privately held, solid tumor-focused Crescent Biopharma Inc. A syndicate of investors has put up $200 million to buy Rockville, Md.-based Glycomimetics common stock and prefunded warrants. Separately, Glycomimetics unveiled the phase II analysis of the adaptive phase II/III study of uproleselan. The study, being conducted by the U.S. National Cancer Institute and the Alliance for Clinical Trials in Oncology in adults with newly diagnosed acute myeloid leukemia who are 60 or older and fit for intensive chemotherapy, failed to provide a statistically significant improvement in event-free survival for patients receiving uproleselan in combination with 7+3 chemo vs. chemo alone.

Coya sinks on phase II Alzheimer’s data, plans more studies

While phase II results of Coya Therapeutics Inc.’s low-dose IL-2 and CTLA4-Ig combination drug, COYA-301, showed promise in Alzheimer’s disease patients when dosed every four weeks, it was the more frequent dosing of every two weeks that led to exhausted regulatory T cells (Tregs) and no benefits, driving down the company’s stock by nearly 30% in early trading Oct. 29. The trial dosed patients for five days every four weeks or every two weeks with COYA-301 or placebo over the 21-week treatment period, showing it was safe and well-tolerated, and led to a significant expansion of Treg populations in the less frequent dosing group without any off-target effects, improving cerebrospinal fluid-soluble Aβ42 levels and stabilizing cognitive function. “Interestingly, increasing the frequency of IL-2 administration to every two weeks had less effect on Treg expansion and the maintenance of FOXP3 expression, particularly toward the end-of-treatment phase,” said Alireza Faridar, the chair of Houston Methodist’s Stanley H. Appel Department of Neurology, during a company call to discuss the results. Coya’s stock (NASDAQ:COYA) fell to $7.15, down $3.04, at midday.

Lexicon looks to go where no other oral drug has gone before

Lexicon Pharmaceuticals Inc. is counting on Thursday’s meeting of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to help it break through the type 1 diabetes (T1D) door with Zynquista (sotagliflozin), proposed as an adjunct to insulin to improve glycemic control in people with T1D and chronic kidney disease. T1D “has been a challenging development space,” Brian Corrigan, Lexicon’s senior vice president for regulatory and quality assurance, told BioWorld. If approved, the dual SGLT-1, 2 would be the only oral adjunct to insulin in the space. But getting through that door may not be so easy. The FDA’s briefing document for the meeting raises several questions about the evidence and the uncertainties surrounding the molecule’s effectiveness, benefit to patients and its risks.

Astellas withdraws its EU MAA for geographic atrophy 

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.

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