Soleno Therapeutics, Inc. (SLNO) stock plummeted 1.77% in the current-market trading session at the price of $0.83 despite no fundamental reason. The last published news was about top-line results from the ongoing open-label extension study of C602. Soleno develops and commercializes novel therapeutics to treat rare diseases. DCCR tablets, its leading drug candidate treat Prader-Willi Syndrome. The drug is currently being evaluated in the Phase-III clinical development program.  

SLNO Published Positive Data about DCCR Tablets 

On 8th September 2021, SLNO published top-line results from its ongoing open-label extension study of C602 and its comparison with data from the PATH for the PWS study. C602 is a multi-centered, randomized, double-blind, and once-daily Diazoxide Choline Extended-Release tablet that treats Prader-Willi syndrome. A total of 115 subjects had enrolled into C602, and about 95 had received DCCR in C602. PATH from the PWS study has sponsored by the Foundation for Prader-Willi Research. The study aims to advance the research related to the natural history of individuals with PWS.  

SLNO will submit data to the FDA as part of an ongoing investigation to support the submission of a New Drug Application to market DCCR. The FDA has previously remarked that another clinical trial development program is required. The agency has also mentioned that open-label data and comparisons with natural history sources for PWS may have limitations. But it has agreed to review the data to decide whether it is suitable to submit an NDA.  

Management Comments 

Paediatric Endocrinologist and Reader at Barts Health NHS Trust and the Queen Mary University of London, Dr. Evelien Gevers, commented that hyperphagia is one of the problems linked with PWS that can have life-threatening results. It has no currently available treatments. These data demonstrate that DCCR had significantly demoted hyperphagia and enhanced body composition, behaviors, and endocrine within 52 weeks. After approval, DCCR will offer people suffering from PWS a meaningful opportunity for long-term guidance of their symptoms, he added.  

Chief Executive Officer of SLNO, Anish Bhatnagar, remarked that they are satisfied with the results from their ongoing open-label extension study for the treatment of PWS. They look onward to submit the data from these studies to the Food and Drug Administration in this quarter. They are committed to obtaining approval for DCCR as a novel treatment of PWS, he added.