Presentation

Company Profile
Saniona is a biopharmaceutical company focused on discovering, developing, and delivering treatments for rare diseases. The company’s lead asset, Tesomet, is in mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, severe rare disorders that cause uncontrollable hunger and intractable weight gain. Saniona’s drug discovery engine has generated a library consisting of more than 20,000 proprietary modulators of ion channels. Lead candidate SAN711 is in a Phase 1 clinical trial and is indicated for the treatment of rare neuropathic disorders. Pre-clinical candidate SAN903 is intended for rare inflammatory and fibrotic disorders.

Recent highlights
In March 2021, Saniona announced that the US FDA granted Orphan Drug Designation (ODD) to Tesomet for the treatment of Prader-Willi syndrome (PWS). In April, the company Saniona announced the receipt of manufacturing feedback from the FDA that delayed the start of the Tesomet Phase IIb trials into the second half of 2021. In June, the company announced that the first patient in the phase I clinical trial of SAN711 had been dosed. In July, the company announced that the US FDA granted ODD to Tesomet for the treatment of hypothalamic obesity (HO).

Outlook
Saniona is preparing to initiate a Phase IIb for Tesomet in patients with Hypothalamic Obesity. The proposed study is a double blind, placebo-controlled trial with a randomisation of 1:1:1:1 (Placebo and 3 doses of Tesomet). Saniona is also planning a Phase IIb trial for Tesomet in patients with Prader-Willi Syndrome, with the study having the same design as the HO trial. The SAN711 compound is currently undergoing a Phase I trial in healthy volunteers, with data expected H1 2022.