Data on Tesomet as Capsule Given to FDA, May Allow Trial in PWS Patients

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by Yedida Y Bogachkov PhD |

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Saniona announced that information requested by the U.S. Food and Drug Administration (FDA) to allow a new trial of Tesomet, a potential treatment for Prader-Willi syndrome (PWS), in a capsule form has been given to the agency.

The company expects these details of the capsule’s manufacturing — requested by the FDA in April — will lead to Phase 2b trials opening in PWS and in hypothalamic obesity patients before year’s end, it said in a press release.

Tesomet, a fixed dose combination of tesofensine and metoprolol, was optimized to be given as a capsule rather than the tablet used previously, Saniona reported. The FDA had agreed to its plans for the new PWS trial, but wanted more information.

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“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.

Tesofensine is a new molecule designed to block the reabsorption of three neurotransmitters, messaging molecules in the brain, into nerve cells: serotonin, noradrenaline, and dopamine. Blocking this re-uptake allows for increased levels of these molecules, helping to reduce food cravings and appetite, and increase fat metabolism.

Although tesofensine has been shown to reduce weight and be well-tolerated, the company found that it can increase heart rhythm and blood pressure. As a result, it is combined with metoprolol, a medication for high blood pressure and heart failure, in Tesomet.

Designated an orphan drug for PWS by the FDA, Tesomet was first developed as a tablet. According to Saniona, capsules have advantages over tablets because many people with Prader-Willi syndrome or hypothalamic obesity have a tendency to chew tablets, which could potentially change the effectiveness of Tesomet’s active ingredients. Like PWS, hypothalamic obesity is a condition that causes an abnormal sensation of hunger.

By containing tesofensine and metoprolol in so-called microspheres, the company hopes to minimize the impact of chewing and biting. In addition, capsules are often easier to swallow than tablets, and make multiple dosing options easier to develop.

“The work we have done to transition Tesomet from tablets to capsules, and to align with the FDA on the supporting … Tesomet capsules, sets us up for success in these two serious rare disorders,” said Haraldsen. “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.”

Results of the Phase 2a clinical trial (NCT03149445) showed that Tesomet can ease uncontrollable hunger (hyperphagia) and promote weight loss in adolescents and adults with PWS.