Saniona, a clinical stage biopharmaceutical company focused on rare diseases, completed the submission of all information requested by the U.S. FDA regarding its chemistry, manufacturing and controls (CMC) program for Tesomet capsules. With this submission completed, Saniona expects to be able to initiate its Phase 2b clinical trials for Tesomet before the end of 2021.
 
Tesomet as a capsule can offer potential advantages over a tablet to people living with Prader-Willi syndrome or hypothalamic obesity. Some of these individuals have a tendency to chew tablets, which could disrupt the effectiveness of the fixed-dose combination of Tesomet’s active ingredients. The Tesomet capsules contain the two active ingredients as microspheres, which are expected to minimize the impact of chewing or biting. Additionally, capsules are generally easier to swallow than tablets and simplify the development of multiple doses.
 
Saniona initiated the work to transition from Tesomet tablets to capsules in late 2020. In April of 2021, the FDA agreed with Saniona’s CMC development plan for Tesomet capsules but had also requested additional information related to the manufacturing of the capsules prior to the initiation of the Phase 2b trials. The requested information has now been submitted.
 
“The work we have done to transition Tesomet from tablets to capsules, and to align with the FDA on the supporting CMC information for the Tesomet capsules, sets us up for success in these two serious rare disorders. We have ensured that our Tesomet capsules are ready for Phase 2b and Phase 3 clinical trials, which provides us with the ability to consider different options to potentially accelerate our clinical development timelines,” said Kyle Haraldsen, Chief Technical Operations Officer for Saniona. “We want to be ready to move as quickly as possible through clinical development so that we may bring Tesomet to patients who are suffering from these conditions.”