Table 1 (abstract O-19).

Result summary of RAPIDe-1 primary and key secondary efficacy endpoints

	Placebo N = 51	PHVS416 10 mg N = 37	PHVS416 20 mg N = 28	PHVS416 30 mg N = 31	Combined PHVS416* N = 96
Mean VAS-3 at pre-treatment	27.76	26.16	25.46	29.73	27.11
Change in VAS-3 at 4 h
Least-squares mean difference:
PHVS416—placebo		− 16.75	− 15.02	− 16.28	− 16.08
p-value		< 0.0001	< 0.0001	< 0.0001
Time to onset of symptom relief by VAS-3 ≥ 30% reductiona
Median time in hours (95% CI)	8.0 (7.6, 46.9)	2.1 (1.5, 2.9)	2.7 (1.9, 3.5)	2.5 (1.9, 3.8)	2.4 (2.0, 2.9)
Hazard ratio		3.81	3.08	3.61
p-value		< 0.0001	0.0021	< 0.0001
Time to VAS-3 ≥ 50% reductiona
Median time in hours (95% CI)	22.8 (20.0, 24.1)	3.3 (2.4, 3.9)	4.0 (2.9, 6.0)	4.0 (3.3, 5.8)	3.9 (3.0, 4.8)
Hazard ratio		4.55	3.65	3.87
p-value		< 0.0001	0.0003	< 0.0001
Time to almost complete or complete symptom relief by VAS-3a
Median time in hours (95% CI)	42.0 (22.0, 48.1)	5.8 (3.6, 7.5)	20.0 (4.5, 20.0)	20.0 (6.0, 20.1)	7.5 (5.9, 20.0)
Hazard ratio		5.09	2.25	2.65
p-value		< 0.0001	0.0127	0.0001
Change in MSCS score at 4 hoursb
Least-squares mean difference:
PHVS416—placebo		− 0.79	− 0.61	− 0.39	− 0.61
p-value		< 0.0001	0.0008	0.0291
TOS at 4 hoursb
Least-squares mean difference:
PHVS416—placebo		64.13	62.69	71.06	66.05
p-value		< 0.0001	< 0.0001	< 0.0001

N = The number of attacks included in the mITT Analysis Set. p-values for PHVS416 20mg and PHVS416 30mg are based on statistical tests in the pre-specified multiple comparison procedure, other p-values are nominal.

^aHazard ratios and p-values are based on marginal Cox proportional hazards models.

^bp-values are based on mixed-effects models for repeated measures.

*The combined PHVS416 results are based on post-hoc analyses to provide a reference of the result by pooling all three active doses.