Bionomics Results Presentation Deck
PREVAIL: A Study to Enable Iterative Late-Stage Development
LIEBOWITZ SOCIAL ANXIETY SCALE
>95: Very severe social phobia i
80-95: Severe social phobia
65-80: Marked social phobia
55-65: Moderate social phobia
ā
12
Participants I/E Criteria
Adults aged 18 to 65 years
DSM-5 based diagnosis of SAD
No psychotropic meds for 30 days
prior to screening
I
Phase 2 Study Design
SCREENING
LSAS score ā„ 70
1:1:1 RANDOMIZATION
(DOUBLE-BLIND)
225mg ~50
675mg ~50
SINGLE ANXIETY CHALLENGE
Placebo ~50
SITES
none
20
PRIMARY EFFICACY MEASURE
SUBJECTIVE UNITS OF DISTRESS SCALE (SUDS):
Visual Analogue Scale (VAS) that measures the self-
reported intensity of anxiety and/or distress.
10
30
40
15 US CENTERS
N-150
Single Dose Administration
mild
PREVAIL Study
50
moderate
60
70
severe
80
90
100
very severe
BionomicsView entire presentation