Tesomet Maker, Saniona, Pauses Phase 2b Clinical Trial for People With PWS

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by Patricia Inacio PhD |

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Saniona will pause the Phase 2b clinical trials testing Tesomet for people with Prader-Willi syndrome (PWS) and hypothalamic obesity (HO).

The decision “is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations,” the company stated in a press release.

The company also announced a reprioritization and restructuring effort that is meant to lead to an immediate reduction in operating expenses, while maximizing cash resources. It will also reduce Saniona’s workforce by about 30%.

“We are extremely disappointed to have to undertake such drastic measures to conserve resources, especially since we know HO and PWS patients and their families are desperately waiting for treatments, and because our employees had made such significant progress in 2021,” Rami Levin, Saniona’s president and CEO, said.

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Tesomet is a fixed-dose combination of tesofensine and metoprolol in a capsule formulation. It is designed to boost the activity of three neurotransmitters (brain signaling molecules) — serotonin, noradrenaline, and dopamine — and, as a consequence, reduce hunger cravings.

The inclusion of metoprolol is meant to lower the risk of heart-related side effects associated with tesofensine. Metoprolol is a medication for high blood pressure and heart failure.

Saniona recently launched a Phase 2b clinical trial (NCT05198362) to evaluate Tesomet’s potential in reducing the uncontrollable hunger (hyperphagia) in people with PWS. The trial was set for multiple locations, including the U.S., Europe, New Zealand, and Australia. Up to 120 PWS participants were to be enrolled, initially adults ages 18 to 65, and then potentially adolescents starting at age 13.

Three doses of Tesomet and a placebo were to be given once daily for 16 weeks (about four months).

Hyperphagia changes, measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), was the trial’s main goal. Secondary goals included assessing changes in body weight and impressions by caregivers and clinicians of overall disease severity and patient health.

Patients completing the first 16 weeks would be eligible to enroll in a 36-week open-label extension, during which all would receive Tesomet at the highest tolerated dose.

Tesomet received orphan drug designation by the U.S. Food and Drug Administration (FDA) last year. Orphan drug status is intended to encourage therapies for rare diseases through benefits that include seven years of market exclusivity and exemption from FDA fees.

“I extend my sincere gratitude to the employees who are affected by this decision; their hard work enabled us to achieve multiple significant milestones in 2021, including obtaining orphan drug designation from the FDA and initiating Phase 2b trials in HO and PWS,” Levin said.

“We are acutely aware of the high unmet need in these disorders and the multiple setbacks the HO and PWS communities have faced; we thank them for their patience as we temporarily pause these trials,” he added.