Clinical Trial – Tesomet for Hypothalamic Obesity.

Saniona today announced the initiation of a Phase 2b clinical trial of Tesomet in patients with hypothalamic obesity.

Tesomet for Hypothalamic Obesity.

Saniona, a clinical stage biopharmaceutical company focused on rare diseases, today announced the initiation of a Phase 2b clinical trial of Tesomet in patients with hypothalamic obesity. Tesomet is an investigational fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. Data from the trial are expected in the second half of 2023.

“The initiation of this Phase 2b clinical trial represents the culmination of the significant work and combined expertise of our clinical, regulatory, technical operations and quality teams,” said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. “We are also preparing to initiate a Phase 2b clinical trial of Tesomet in Prader-Willi syndrome before the end of the year, which, combined with our ongoing Phase 1 trial for SAN711, means our team will end the year with three rigorous clinical programs underway.”

The Phase 2b clinical trial includes a randomized, double-blind, placebo-controlled 36-week treatment period followed by a 36-week open-label extension period. The trial will seek to enroll approximately 110 participants 16 years of age and older with hypothalamic obesity a rare disease caused by damage to the hypothalamus. During the 36-week double-blind period, participants will be randomized to receive daily doses with Tesomet at one of three dose levels or placebo.

During the 36-week open-label extension period, all participants, including those who originally received placebo, will receive the highest tolerated dose of Tesomet as established during the double-blind period. The primary endpoint of the study is the percentage change in body weight from baseline to week 36. Secondary endpoints include the proportion of participants who meet pre-specified thresholds for body weight loss at week 36, as well as change from baseline to week 36 in body weight, waist circumference, and body mass index.

The clinical trial is being conducted at multiple sites around the world, including in the United States, New Zealand, Australia, and in multiple countries in Europe including the United Kingdom, Sweden, Italy, Spain and others.

Amy Wood, Executive Director of the Raymond A. Wood Foundation and parent of a child living with hypothalamic obesity, commented, “Hypothalamic obesity is a devastating condition that causes excessive weight gain even when food is limited and there are currently no FDA-approved treatments. Earlier this year, the FDA awarded Tesomet the first-ever orphan drug designation for HO, which was a significant milestone for the HO community, and we are so excited to now see another milestone achieved with the initiation of the trial.”

“Management of hypothalamic obesity is extremely difficult because standard approaches to treating obesity, such as lifestyle counseling, medications for general obesity, and even surgery are largely ineffective in this population,” said Ashley Shoemaker, Attending Physician, Assistant Professor of Pediatrics, Pediatric Endocrinology, Vanderbilt University Medical Center.

“We desperately need treatment options for HO, and I am encouraged to see Saniona initiate this clinical trial.” 

Saniona previously evaluated Tesomet in a randomized, double-blind, placebo-controlled initial Phase 2 trial in adults with HO. In the study, Tesomet was generally well tolerated and led to a statistically significant reduction in body weight, as well as improvements in waist circumference and glycemic control.

Saniona is also evaluating Tesomet for the treatment of Prader-Willi syndrome and plans to begin a Phase 2b trial in in this indication before the end of this year. The FDA granted Tesomet orphan drug designation in PWS in March 2021.



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