Vistagen reports positive preliminary OLE data for fasedienol in SAD; well-tolerated up to 12 months

Vistagen Therapeutics, Inc.

OLE safety (n=341): discontinuation due to AEs 2.6%; no SAEs related to fasedienol; TEAEs >5%: headache 10.9%, URI 11.4%.
LSAS mean improvement: 16.3 pts at Month 1, 25.4 pts at Month 4; 56% had >=20 pt improvement at Month 4.
SPIN mean improvement: 7.9 pts at Month 1, 12.4 pts at Month 4; 55% had >=10 pt improvement at Month 4.
Baseline LSAS mean 99.2 (very severe SAD); baseline SPIN mean 48.7 (severe); improvements seen on both fear/avoidance subscales.
Non-responders in randomized portion showed comparable LSAS improvement: Month 1 =13.4, Month 4 =20.8, 50% >=20 pts.

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