Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
Biomea Fusion Inc. has released preclinical findings from a 28-day weight loss study in obese nonhuman primates evaluating BMF-650, a next-generation oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1RA).
Biomea Fusion Inc. has prepared new fused pyrimidine compounds acting as menin (MEN1)/KMT2A (MLL) interaction inhibitors. They are reported to be potentially useful for the treatment of cancer, osteoporosis, autoimmune diseases, inflammatory diseases, type 1 and 2 diabetes.
Released from a clinical hold by the U.S. FDA in late September, Biomea Fusion Inc.’s menin inhibitor, icovamenib, has charged ahead to produce positive top-line data from a phase II study in type 2 diabetes (T2D). The data, however, didn’t stop the stock from dropping to near its lowest level of the past 12 months.
The U.S. FDA has lifted the full clinical hold it imposed in June on Biomea Fusion Inc.’ s phase I/II studies of BMF-219 in types 1 and 2 diabetes. A safety review of the phase IIb expansion study was encouraging and none of the elevated lab values confirmed serious liver injury or impairment, said Biomea’s CEO, Thomas Butler.
The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219 for treating type 1 diabetes and type 2 diabetes. The hold sank the stock on June 7 as the company looked to find answers so it could sit down with the agency to discuss next steps.
Fused pyrimidine compounds acting as menin (MEN1)/MLL interaction inhibitors have been described in a Biomea Fusion Inc. patent and reported to be useful for the treatment of cancer, osteoporosis, autoimmune and inflammatory diseases, among others.
Biomea Fusion Inc.’s diabetes treatment produced enhanced glycemic control at week 26 courtesy of its 200-mg cohort. It’s the latest advance for the company’s candidate that also has strong prospects in treating leukemia. Top-line data from the ongoing phase II Covalent-111 study of BMF-219, a covalent menin inhibitor for regenerating insulin-producing beta cells, demonstrated that about 40% of participants, four of 11 patients, in the 200-mg cohorts showed a durable reduction, 1% or more, in the amount of blood sugar attached to the type 2 diabetes (T2D) patients’ hemoglobin. The data came from participants who had received the last dose in a four-week treatment.
As earlier-stage efforts in oncology continue with BMF-219, Biomea Fusion Inc. rolled out new clinical data June 23 from the first two cohorts of patients with type 2 diabetes enrolled in the phase II part of its ongoing phase I/II study called Covalent-111 testing the same compound, an oral covalent menin inhibitor.
Research at Biomea Fusion Inc. has led to the development of GTPase KRAS (G12C mutant) and (G12D mutant) inhibitors potentially useful for the treatment of cancer, autoimmune disease and inflammatory disorders.
