Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader-Willi Syndrome - Seite 2

Analysis of Primary Endpoint

	Top-line analysis June 2020		Data through March 1, 2020
	DCCR (N=82)	Placebo (N=42)	DCCR (N=80)	Placebo (N=41)
Change from Baseline in Hyperphagia	-5.94 (0.88)	-4.27 (1.15)	-6.64 (1.00)	-3.51 (1.28)
LS Mean Difference [DCCR-Placebo]	-1.67		-3.13
p-value	0.198		0.037

Key Secondary Endpoints

	Top-line analysis June 2020 p-value	Data through March 1, 2020 p-value
Clinical Global Impression of Improvement (CGI-I) at Visit 7	0.03	0.015
Change from Baseline in Body Fat Mass (DXA) at Visit 7	0.03	0.004
Caregiver Global Impression of Change (Caregiver GI-C) at Visit 7	0.41	0.031

In addition to the pre-COVID-19 data presented by Soleno at the webinar, Theresa Strong, Ph.D., co-founder and Director of Research Programs at the Foundation for Prader-Willi Research, provided an overview of the impact of the COVID-19 pandemic on more than 300 PWS patients and their families. Results from the Global PWS Registry’s “Impact of COVID” Survey emphasized that PWS patients and their caregivers have experienced significant disruptions due to the COVID-19 pandemic. A significant proportion of caregivers (85%) reported more stress. For patients, lack of social activity, remote learning and the loss of in-person therapy have had a substantial negative impact, with the loss of routine and structure contributing to increased challenges in food control and behavioral management.

Jennifer Miller, M.D., Director of the University of Florida Health Prader-Willi Syndrome Program and a Professor in the Division of Pediatric Endocrinology at the UF Department of Pediatrics, provided a summary of PWS and the obstacles faced by PWS patients and their families. Dr. Miller also reviewed the current treatment landscape and unmet need in PWS, as well as the positive biochemical, physical, and behavioral changes observed to date with DCCR treatment in her patients.