Vertex: VX-548 preclinical studies, Phase 2, proof-of-concept results published

Vertex Pharmaceuticals announced publication in the New England Journal of Medicine NEJM of preclinical data and the results from its Phase 2 proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty and bunionectomy surgeries. “VX-548 preclinical studies demonstrated high selectivity and potency for the NaV1.8 sodium channel which translated into Phase 2 clinical results with strong efficacy, a favorable benefit-risk profile and promise in the treatment of acute pain,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “Our Phase 3 trials for VX-548 are well underway, and we look forward to the potential of bringing an effective, non-opioid therapeutic option to patients suffering from moderate to severe acute pain.” Vertex expects to complete the pivotal program in late 2023 and share results from these studies in late 2023 or early 2024. VX-548 has been granted Breakthrough Therapy and Fast Track designations in the U.S. for moderate to severe acute pain. In addition, Vertex has initiated a Phase 2 dose-ranging study of VX-548 in neuropathic pain.