Neurodon announced today that it initiated studies to prepare an FDA Investigational New Drug (IND) application for its type 1 diabetes treatment.
Crown Point, Ind.-based Neurodon’s NDC-0009 novel molecule targets endoplasmic reticulum (ER) stress, a pathway triggered by factors arising from disease that features in type 2 and type 2 diabetes, as well as inflammation and neurodegenerative disorders, according to a news release.
The oral treatment has proven to be well-tolerated in animals with repeat dosing and showed capabilities with regulating glucose and preserving insulin function in those animals, as well as in pancreatic β-cells from human donors.
Neurodon VP of operations Colleen Mauger said in the release that, following a 2019 angel investment to fund its diabetes program, the company has made “rapid-fire progress” to reach this point, with hopes of initiating clinical trials for NDC-0009 in the second half of 2022.
“We are excited to achieve this milestone with the selection of a development candidate for our diabetes program. Our molecules have demonstrated compelling efficacy in both animal models and human pancreatic islets, and we are focused on developing first-in-class therapeutics to meaningfully impact those living with T1D,” Neurodon CEO Russell Dahl said in the release. “We look forward to translating our drug’s ability to restore insulin production in pancreatic islet cells to provide disease-modifying options for patients.”