Vertex's Non-Opioid Diabetes Associated Nerve Pain Treatment Candidate Aces Mid-Stage Trial

Vertex Pharmaceuticals Incorporated VRTX released results from its Phase 2 dose-ranging study of VX-548 (non-opioid pain medicine) for diabetic peripheral neuropathy, a type of nerve damage caused by high blood sugar. 

VX-548 was generally well tolerated at all doses tested in the study.

Patients were randomized to VX-548 once daily at 69 mg (high dose), 46 mg (mid dose), or 23 mg (low dose), or the reference arm of pregabalin 100 mg three times per day (TID) for 12 weeks.

All VX-548 treatment groups showed statistically significant and clinically meaningful reductions from baseline in pain with mean change in Numeric Pain Rating Scale (NPRS) at Week 12 of -2.26, -2.11, and -2.18 at the high, mid, and low doses, respectively. 

The pregabalin reference arm mean change from baseline in NPRS at Week 12 was -2.09 and is provided for context. 

All VX-548 dose groups had sustained mean reductions in pain from baseline starting at Week 1, with pain continuing to decrease until Week 5, which was then maintained throughout the treatment period.

In the responder analysis, more than 30% of patients treated with VX-548 achieved ≥50% reduction in all dose groups, and more than 20% in mid-and high-dose groups achieved ≥70% reduction. 

In the pregabalin reference arm, 22% of patients achieved ≥50% reduction, and 10% achieved ≥70% reduction in the weekly average pain scale at Week 12 compared to baseline.

Vertex has also initiated a second Phase 2 study of VX-548 in peripheral neuropathic pain. Additionally, the three Phase 3 studies of VX-548 in acute pain are on track to read out in Q1 of 2024.

Price Action: VRTX shares are up 11.02% at $397.16 on the last check Wednesday.

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