- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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