Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy

Published

– Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) –

– Placebo arm showed similar within-group reduction in NPRS –

– Suzetrigine was generally well tolerated –

– Advancement to Phase 3 in painful lumbosacral radiculopathy planned, pending discussions with regulators –

– Vertex to host investor call on December 19 at 8:00 a.m. ET –

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from its Phase 2 study of suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor in people with painful lumbosacral radiculopathy (LSR). The study met its primary endpoint with statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS).

Efficacy Results

The study’s primary endpoint was a within-group change from baseline in the weekly average of daily leg pain intensity on the NPRS at Week 12. This 11-point scale ranges from 0 (no pain) to 10 (worst pain imaginable).

The suzetrigine arm showed a statistically significant and clinically meaningful within-group reduction from baseline in pain with a mean change in NPRS at Week 12 of -2.02.

The study also included a placebo reference arm which showed a similar within-group reduction from baseline in pain with a mean change in NPRS at Week 12 of -1.98. The study was not designed nor powered for statistical comparison between suzetrigine and placebo.

 

Suzetrigine N = 102

Placebo N = 100

Baseline NPRS

 

 

Mean NPRS (SD)

6.33 (1.22)

6.05 (1.07)

Change in NPRS from baseline at Week 12

 

 

LS mean

-2.02

-1.98

95% CI

(-2.40, -1.64)

(-2.36, -1.60)

P value

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