Vertex shares tumble following Phase 2 pain study results

Investing.com -- Shares of Vertex Pharmaceuticals (NASDAQ:VRTX ) Incorporated (NASDAQ:VRTX) fell 12% today after the company announced results from its Phase 2 study of suzetrigine. The investigational pain signal inhibitor met its primary endpoint but failed to show a significant difference from the placebo, casting doubt on the drug's efficacy.

The study, which focused on patients with painful lumbosacral radiculopathy (LSR), reported a statistically significant and clinically meaningful within-group reduction from baseline in pain on the Numeric Pain Rating Scale (NPRS) at Week 12 in the suzetrigine arm. However, the placebo arm showed a similar reduction, which has raised questions about the drug's effectiveness. The primary endpoint was the within-group change from baseline in the weekly average of daily leg pain intensity on the NPRS, with the suzetrigine arm achieving a mean change of -2.02 points.

Despite the drug meeting the primary endpoint, the lack of separation from the placebo's -1.98 point improvement has led to skepticism. Stifel analyst Paul Matteis commented on the results, stating, "In our view, the suzetrigine LSR result looks like a pretty clear negative: the drug and placebo arms both improved by ~2 points on the NPRS at week 12, which is pretty unequivocal."

While Vertex acknowledged the high placebo response in the study, the company is committed to advancing suzetrigine to Phase 3, planning to innovate the study design to better control for the placebo effect. Vertex also highlighted the drug's generally well-tolerated safety profile, with no serious adverse events related or possibly related to suzetrigine.

The company is also pursuing regulatory discussions for suzetrigine's advancement in treating painful LSR and continues its suzetrigine pivotal program in painful diabetic peripheral neuropathy (DPN). Additionally, suzetrigine is under FDA review for the treatment of moderate-to-severe acute pain, with a PDUFA target action date of January 30, 2025.

As the market reacts to the Phase 2 results, investors will be closely watching Vertex's next steps and the potential adjustments to the clinical trial designs that aim to address the challenges observed in the current study.

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Source: Investing.com