Benzinga | May 4, 2021 08:07AM EDT

Soleno Therapeutics Announces Presentation Of Behavioral Data From Ongoing Extension Study Of DCCR For Treatment Of Prader-Willi Syndrome; Says 'Results Show Improvement in Multiple Behavioral Domains Following Treatment with DCCR'

Soleno Therapeutics, Inc. ("Soleno") (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the presentation of positive behavioral outcomes data from the Company's ongoing open-label extension study (C602) of DCCR (diazoxide choline) Extended-Release tablets for patients with Prader-Willi Syndrome (PWS), at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting. The poster is available here.

As part of the ongoing Phase 3 program of DCCR in PWS, interviews are being conducted with caregivers of C602 study participants to characterize individual patient experiences with DCCR. The interviews are performed at multiple timepoints during the Phase 3 program by Casimir Inc., a rare disease research organization. The poster highlights the analysis of a subset of 48 interviews of caregivers whose child had received at least 13 weeks of DCCR treatment in C602. Folia Health, which utilizes a data driven platform to improve the treatment of chronic conditions, utilized a combination of natural language processing (NLP) and qualitative analytic techniques to process and analyze the transcript data from the caregiver interviews.

Through the 48 interviews, 39 behavioral outcomes were identified in seven outcome domains, with an average of 22?5.9 behaviors reported. The three most frequently reported domains were Food-seeking Behaviors (100%), Mealtime Behaviors (98%), and Daily Life Behaviors (98%). Twenty three percent of participants reported a negative behavior change and 6% reported more than one negative change. Most participants (83%) reported positive change in one or more behavioral outcomes on DCCR, more than 70% reported positive changes in one quarter or more of behaviors, while 48% reported positive changes in more than half of behaviors.

"It is exciting to see the utilization of natural language processing for the first time to determine caregiver sentiment in patients with PWS. NLP and other artificial intelligence techniques are the future of qualitative data analysis and can be particularly useful in rare-disease research. To my knowledge, this is the first report of the use of such techniques to understand the complex world of PWS outcomes," said Deepan Singh, M.D., Vice Chair of Ambulatory Psychiatry, Maimonides Medical Center in Brooklyn, NY. "Behavioral abnormalities in PWS are heterogenous and very difficult to treat. I am encouraged by DCCR's potential to impact these intractable problematic behaviors in individuals with PWS."

"These important data provide critical insights into the long-term behavioral responses to DCCR in PWS, and support a more complete view of this promising investigational drug's therapeutic benefits," said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. "The growing body of clinical evidence continues to indicate that DCCR has the potential to address the significant need for a safe and effective treatment for individuals with PWS. We remain firmly committed to working with the U.S. Food and Drug Administration to define the path forward for DCCR."