Soleno tanks as FDA calls for additional trial of Prader-Willi candidate

US biotech Soleno Therapeutics (Nasdaq: SLNO) has provided an update following recent interactions with the US Food and Drug Administration regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi Syndrome (PWS), revealing that the regulator had called for additional clinical data and sending the firm’s shares tumbling nearly 50% to $1.38 by close of trading yesterday.

Subsequent to the previously disclosed Type C meeting with the FDA on November 12, 2020, regarding the potential adequacy of data from studies with DCCR to support a New Drug Application (NDA) for the treatment of PWS, Soleno submitted additional analyses to the FDA from the company’s Phase III trial, DESTINY PWS (C601).

These data were from study visits that were completed prior to the significant disruptions caused by the COVID-19 pandemic. The data analyses showed statistically -significant changes for DCCR compared to placebo in the primary and key secondary endpoints. Following its review of the data submitted by Soleno, the FDA informed the company on March 5, 2021 that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR in PWS.