Saniona announced July 26th that the U.S. Food and Drug Administration had granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity (HO).
Tesomet is the first and only investigational treatment for HO to receive orphan drug designation, the company states.
Saniona is preparing to initiate two Phase 2b studies of Tesomet in the second half of this year, one in HO and the other in Prader-Willi syndrome (PWS), for which Tesomet has already received orphan drug status.
A Phase 2 trial
Saniona previously evaluated Tesomet in a 24-week, double-blind, randomized, placebo-controlled initial Phase 2 trial in HO. Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control. These improvements were maintained during an additional 24-week open-label extension. Tesomet was reported to be generally well-tolerated, and most adverse events were mild.
The Phase 2b study
In preparation for the initiation of the Phase 2b study of Tesomet in HO in the second half of 2021, Saniona has selected the clinical research organization (CRO) that will support the clinical trial and is in the process of assessing and selecting clinical trial sites in the U.S. and globally. Saniona has also selected the contract manufacturer to produce Tesomet for Phase 2b and Phase 3 clinical trials.
Additionally, Saniona has initiated multiple partnerships with the HO advocacy community to incorporate caregiver and patient feedback into the clinical trial process and to provide the community with education on clinical trials, it states.
Saniona is also evaluating Tesomet for the treatment of Prader-Willi syndrome (PWS) and plans to begin a Phase 2b trial in this indication in the second half of this year. The FDA granted orphan drug designation to Tesomet for the treatment of PWS in March 2021.
Photo of Rami Levin, CEO, Saniona