Anvumetostat

Amgen adopted adezkibart from its monumental $27.8 billion buyout of Horizon Therapeutics in 2023.\n Amgen has pulled the plug on midstage drug candidates for cancer and the autoimmune disease Sjögren’s syndrome, terminating five clinical trials in the process.The Big Pharma has scrapped AMG 329, also known as adezkibart, for Sjögren’s after a phase 2 trial failed an interim futility analysis, a spokesperson confirmed to Fierce Biotech. Amgen adopted adezkibart, an antibody targeting FMS-like tyrosine kinase 3 ligand, from its monumental $27.8 billion buyout of Horizon Therapeutics in 2023. The molecule joins another recently discontinued Sjögren’s candidate on the Big Pharma scrap heap, courtesy of Astellas dropping a small molecule STING inhibitor for the disease during its own recent pipeline cleaning.Sjögren’s syndrome is an autoimmune disease in which the patient’s immune system attacks the tear and salivary glands, leading to symptoms like dry eyes and mouth. The FDA has never approved a drug specifically designed to treat Sjögren’s, with symptoms often managed by anti-inflammatory medications.Despite dropping adezkibart, Amgen hasn’t given up on Sjögren’s. The company still has a CD40 ligand-blocking fusion protein called dazodalibep in a pair of phase 3 trials for the condition.“These studies address both systemic and symptomatic disease, and both are expected to complete later this year,” Amgen’s Chief Scientific Officer Jay Bradner, M.D., told investors in an April 30 earnings call.By blocking CD40 ligand, Amgen hopes dazodalibep can dull the haywire inflammation that marks Sjögren’s.“What is true of Sjögren’s disease, whether or not it\'s systemic or symptomatic, is that T and B cell activation is the primary driver,” Bradner said during the call. “This isn\'t a dry gland disease; it\'s enriched with inflammatory cells,” the CSO added. “We believe that CD40 ligand is the right lever to press on, as it will impact all downstream signaling by targeting the upstream CD40 ligand on T cells.”With adezkibart discontinued, Amgen’s pipeline seems to have just one remaining investigational asset from its Horizon buyout, which centered on the already approved drugs Uplizna, Krystexxa and Tepezza. That lone remaining candidate is AMG 732, formerly known as HZN-280, an antibody targeting insulin-like growth factor-1 receptor in phase 2 development for thyroid eye disease.Amgen also revealed in its first-quarter earnings documents that it has ended work on another drug, called AMG 193 or anvumetostat. The small molecule, which is designed to inhibit protein arginine methyltransferase 5, was being evaluated for lung cancer, solid tumors, pancreatic cancer and thoracic cancers.Amgen stopped four phase 1b or phase 2 trials of anvumetostat after “the overall efficacy observed did not meet our high bar for additional internal investment,” a company spokesperson explained to Fierce.

New name, new formulation for Novo's oral diabetes drugAmgen discontinues assets for Sjögren's disease, cancerNew name, new formulation for Novo's oral diabetes drugNovo Nordisk said that starting Monday, it will begin selling a rebranded and reformulated version of its type 2 diabetes drug Rybelsus (semaglutide) as the Ozempic pill. The new offering will be available in the US through standard pharmacies, as well as through the company's self-pay platform NovoCare Pharmacy and other telehealth providers. The Danish drugmaker has marketed oral semaglutide as Rybelsus to type 2 diabetes patients since its FDA approval in 2019 at strengths of 3 mg, 7 mg and 14 mg. The original dosages have been reformulated, and the GLP-1 receptor agonist will now be offered as the Ozempic pill at doses of 1.5 mg, 4 mg and 9 mg. According to Novo, the treatment has "the same efficacy and safety profile as the original formulation, offered in a smaller pill."The low, middle and high doses of the Ozempic pill will have monthly self-pay price tags of $149, $199 and $299, respectively, when purchased via NovoCare Pharmacy.The decision to rebrand the diabetes treatment, according to the pharma, was "to help patients and healthcare professionals more easily recognise the available treatment options for type 2 diabetes that contain the semaglutide molecule." Novo has an application under review with the FDA seeking approval of a 25-mg oral dose of Ozempic in adults with type 2 diabetes; a decision is expected by year-end. Amgen discontinues assets for Sjögren's disease, cancerAmgen disclosed in its first-quarter earnings report that it has stopped development of two programmes: anvumetostat (AMG 193) and adezkibart (AMG 329). The former was discontinued "following a comprehensive review of the oncology profile and emerging AMG 193 clinical data."Amgen had been evaluating anvumetostat, a second-generation PRMT5 inhibitor, across four early- to mid-stage clinical studies for indications including methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non–small-cell lung cancer; MTAP-null solid tumors; MTAP-null thoracic malignancies; and advanced MTAP-null gastrointestinal, biliary tract or pancreatic cancers. The second asset, adezkibart, is a mAb directed against FLT3L. It was being studied in a Phase II trial for Sjögren's disease, but the trial was stopped after it "met pre-defined criteria for futility," Amgen said.