13.12.2023 12:46:51
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Vertex Announces Positive Results From Phase 2 Study Of VX-548 In Diabetic Peripheral Neuropathy
(RTTNews) - Vertex Pharmaceuticals Inc. (VRTX) announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy or DPN.
The company stated that treatment with all doses of VX-548 resulted in a statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the weekly average of daily pain intensity on a Numeric Pain Rating Scale at Week 12. The study also included an active reference arm of pregabalin to support the evaluation of the VX-548 treatment effect.
VX-548 was generally well tolerated at all doses tested in the study. Most adverse events were mild to moderate and there were no serious adverse events related to VX-548.
Vertex said it plans to advance VX-548 into pivotal development following discussions with regulators.
Vertex has also initiated a second Phase 2 study of VX-548 in peripheral neuropathic pain. This trial will evaluate VX-548 in patients with painful lumbosacral radiculopathy, or LSR, which is pain caused by impairment or injury to nerve roots in the area of the lumbar spine.
In addition, the three Phase 3 studies of VX-548 in acute pain are on track to read out in the first quarter of 2024.
Vertex noted that it continues to advance preclinical and clinical development of additional NaV1.8 and NaV1.7 inhibitors, for use alone or in combination, in acute and neuropathic pain.
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Vertex Pharmaceuticals Inc. | 444,40 | 5,26% |