Saniona has completed the submission of all information previously requested by the FDA regarding its chemistry, manufacturing and controls (CMC) program for Tesomet capsules. As a result, the company expects to be able to initiate clinical phase IIb studies in the rare diseases Hypothalamic Obesity and Prader-Willi Syndrome with Tesomet this year, as planned.
In preparation for phase II and phase III clinical studies and subsequent commercialisation of Tesomet in Prader-Willi syndrome (PWS) and hypothalamic obesity (HO), Saniona began to take several steps to optimise Tesomet at the end of 2020. An important part of these efforts was to transition from tablets to capsules.
On April 22, 2021, Saniona received feedback from the FDA regarding its proposed chemistry, manufacturing and controls (CMC) plans for Tesomet. Although the FDA expressed support for the company’s plans to change administration form from tablets to capsules, it requested additional information on the production of Tesomet. This delayed the start of the two phase IIb clinical trials until the second half of 2021.
Clear benefits with capsules for the patient groups
Tesomet is a fixed-dose combination of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). The company chose to use a capsule formulation because some individuals with PWS and HO tend to chew on tablets, which Saniona believes would disrupt the performance of the fixed-dose combination. The Tesomet capsules contain the two active ingredients as microspheres, which are expected to minimise the impact of chewing or biting. Additionally, capsules are generally easier to swallow than tablets and facilitate the development of multiple dosage strength options.
Manufacturing data submitted to FDA
Yesterday, Saniona announced that it has completed the submission of all information previously requested by the FDA regarding its chemistry, manufacturing and controls program for Tesomet capsules. Saniona expects to be able to start phase IIb clinical studies with Tesomet before the end of 2021.
In a press release, Kyle Haraldsen, Chief Technical Operations Officer at Saniona, said:
»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 IIb and Phase III clinical trials, which provides us with the ability to consider different options to potentially accelerate our clinical development timelines. 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«
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