Saniona finishes six months double blind Phase 2a trial of Tesomet

Saniona, a renowned biopharmaceutical firm focusing on rare disorders of the central nervous system, has reportedly announced that the last patient has successfully completed the last visit in the company’s six-month, double blind Phase 2a study of Tesomet in HO (Hypothalamic Obesity).

A total of 18 patients, from the initial 21 who had started the trial, have now resumed the open-label extension part of the study. The placebo-measured part of the study remains on track to report top-line results in the second quarter of 2020.

Rami Levin, CEO, Saniona, stated that the company is thrilled that the Phase 2a trial of Tesomet is beginning as per the plan, at a time of such ambiguity and disruption across the globe caused by the COVID-19 virus.

Levin further stated that the study is an essential part of the clinical package which Saniona is accumulating, as the company is quickly advancing Tesomet for pivotal clinical trials in the rare eating disorder of HO as part of its long-term strategy of becoming a globally recognized commercial stage biopharma company.

The Phase 2a study is a double-blind, randomized, placebo-controlled, exploratory Phase 2a trial in patients with disorder of HO, led at  Rigshospitalet in Copenhagen, Denmark. Under the trial, patients have received either matching placebo or Tesomet for 24 weeks. This is followed by an open-label expansion study where all patients would get Tesomet for 24 weeks bringing about a complete treatment period of 48 weeks. Saniona hopes to report the outcomes from the double-blind part of the study in the second quarter of 2020.

The key endpoint is total tolerability and safety, which would be determined after considering all the safety data collected during the study, which includes laboratory data, recorded adverse events, heart rate, and blood pressure. The secondary endpoints are related to body composition; appetite & satiety; quality of life; bodyweight; craving for salty, sweet, and fatty foods; and metabolic parameters & lipids.

Source credit: https://www.bioportfolio.com/news/article/4253602/Saniona-completes-its-six-months-double-blind-Phase-2a-trial-of-Tesomet.html