Soleno Therapeutics' DCCR Shows Benefit On Hunger, Behavioral Parameters

Soleno Therapeutics Inc SLNO has announced top-line results from its ongoing open-label extension study evaluating DCCR (Diazoxide Choline) Extended-Release tablets for Prader-Willi syndrome (PWS).
The mean (SE) improvement in hyperphagia (extreme hunger) was highly significant after receiving DCCR for 52 weeks.
After 52 weeks, there were statistically significant improvements in all behavioral domains.
Related: Soleno Therapeutics' DCCR Treatment Shows Behavioral Improvement In Prader-Willi Syndrome.
The PATH from PWS subjects showed a mean (SE) change of -2.5 (0.38) and -3.4 (0.48) after 26 and 52 weeks compared with that of -8.4 (0.72) and -9.4 (0.74) in matched C602 subjects, showing a statistically significant improvement with DCCR.
Patients in study C602 showed no significant change in body fat mass and statistically significant improvements in lean body mass and the ratio of lean body mass to fat mass.
Subjects demonstrated highly significant improvements in leptin, adiponectin, and fasting insulin.
Significant improvement in insulin sensitivity was also observed.
The FDA has previously conveyed to Soleno that another trial will likely be needed and that open-label data and comparisons with natural history sources may have statistical and other limitations.
Still, it has agreed to review the data to determine whether it is appropriate for the Company to submit an NDA.
Price Action: SLNO shares are down 2.95% at $0.86 during the market session on the last check Wednesday.

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