Roivant Sciences, a global healthcare company focused on realizing the full value of promising biomedical research, and POXEL SA, a French biopharmaceutical company focused on the development of innovative treatments for metabolic disorders including type 2 diabetes, announced the signing of a strategic development and license agreement for imeglimin, an investigational oral therapy which has been developed by Poxel for the potential treatment of type 2 diabetes, in the U.S., Europe, and all other countries not covered by Poxel’s existing agreement in East and Southeast Asia.
This partnership enables Switzerland-based Roivant to add an innovative late-stage development program to its pipeline and Poxel gains a strategic development and licensing agreement for imeglimin beyond the company’s partnership with Sumitomo Dainippon Pharma.
“We are pleased to have reached this agreement with Poxel as we continue our strategy of in-licensing late-stage development candidates in underserved therapeutic areas,” said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. “This agreement represents the beginning of our focus on metabolic diseases and imeglimin, with its compelling and consistent data, will be a cornerstone program. We are looking forward to rapidly advancing its development.”
Activities in 2018 to support initiation of the Phase 3 program will include differentiation studies to confirm imeglimin’s potential in sensitive patient populations, such as those with chronic kidney disease, as well as manufacturing of the drug product for use in the Phase 3 program. The goal is to initiate the Phase 3 program in the U.S. and Europe in 2019.
Imeglimin has completed Phase 1 and Phase 2 development in 18 clinical studies involving over 1,200 subjects with type 2 diabetes in the U.S., Europe, and Japan, and met its primary and secondary endpoints, including a statistically significant decrease of HbA1c and fasting plasma glucose versus placebo, with a favorable side effect profile.