Saniona has announced results from its 24-week double blind, randomized, placebo-controlled Phase 2 trial evaluating the safety and efficacy of Tesomet in patients with hypothalamic obesity (HO).
The study results showed that Tesomet was safe and well tolerated. Furthermore, efficacy data was also reported, with statistically significant improvements in body weight, waist circumference, and glycemic control observed with Tesomet treatment compared to placebo, reports the company.
“We are highly encouraged by the promising safety and efficacy observed in our Phase 2 randomized controlled trial,” says Rami Levin, President and Chief Executive Officer of Saniona. “This is an important accomplishment that we believe is a step forward towards a possible first approved treatment for HO. We recognize the importance of discovering a treatment for this devastating rare disease and are committed to rapidly advancing Tesomet for HO patients. We are evaluating next steps for the development of Tesomet in Hypothalamic Obesity and intend to pursue an End of Phase 2 meeting with FDA to define a regulatory path forward.”
“Patients with hypothalamic obesity are faced with severe and debilitating overweight for which there is no approved treatments. I am highly encouraged by the study results, and I believe that Tesomet may become a valuable treatment of this rare disease, including management of the key characteristics of the disease such as: persistent hunger, loss of appetite control, uncontrollable weight gain and metabolic dysfunction. Equally important is the favorable safety and tolerability profile of Tesomet, which is highlighted by the fact that only one patient on Tesomet did not continue to the open-label study extension. These promising results warrant further studies and I look forward to the continued development of Tesomet as a potential first treatment to improve outcomes for patients with hypothalamic obesity,” says Professor Ulla Feldt-Rasmussen, Department of Medical Endocrinology and Metabolism, Rigshospitalet Copenhagen University Hospital and Principal Investigator on the Phase 2 study.
Photo of Rami Levin: Saniona