Diasome’s HDV-Insulin for T1D Finalizing Phase III Plans After Promising Data
HDV is intended to address the difficulty of insulin, GLP-1, or other molecules traveling to the liver when injected subcutaneously, due to the large number of receptors in peripheral tissue such as fat cells and muscle cells. The post Diasome’s HDV-Insulin for T1D Finalizing Phase III Plans After Promising Data appeared first on GEN - Genetic Engineering and Biotechnology News .
Diasome, a company based in New Orleans, is developing a next-generation formulation of insulin for type 1 diabetes (T1D) treatment. This innovative approach targets hepatocytes, the cells responsible for regulating blood glucose and fat metabolism, using its hepatocyte-directed vesicle (HDV) lipid nanoparticle platform. The HDV platform is designed to deliver insulin, GLP-1, and serotonin to the liver more effectively, enhancing cellular uptake and bioavailability.
Robert Geho, Diasome's co-founder and CEO, explained that the HDV platform allows for the preferential delivery of insulin and other molecules into the liver and portal vein, bypassing peripheral tissue such as fat cells and muscle cells. This targeted approach aims to address the challenges of delivering insulin, GLP-1, and other molecules to the liver when injected subcutaneously.
Diasome has generated promising Phase IIb data, which has been presented at conferences earlier this fall. The company is now working on finalizing its Phase III plans, including finalizing the protocol, conducting power calculations, and selecting the insulin to be used in the pivotal studies. Geho, himself a T1D patient, emphasized the importance of this advanced treatment for T1D patients.
Despite the existence of various treatments for T1D, such as insulin and adjunctive therapies, the development of new treatments continues. Lexicon Pharmaceuticals, for example, is preparing to resubmit a new drug application for sotagliflozin in T1D, based on positive Phase III STENO1 trial data. However, the FDA had previously rejected Lexicon's NDA for sotagliflozin as an add-on therapy to insulin for adults with T1D and chronic kidney disease.
Other T1D drug candidates, such as dapagliflozin and acmopatide, have also faced challenges. Dapagliflozin was rejected by the FDA in 2019 and 2020, respectively, while acmopatide was discontinued by Roche in favor of focusing on enicepatide, a once-weekly subcutaneous injectable. These developments demonstrate the ongoing efforts in the T1D drug landscape to improve treatment options for patients.
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