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Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain

  • Proof-of-concept study of VX-548 in acute pain following bunionectomy surgery open for enrollment.
  • Second Phase 2 study of VX-548 in acute pain following abdominoplasty surgery to begin in the coming weeks.

Vertex Pharmaceuticals Incorporated today announced that it has begun a Phase 2 proof-of-concept (POC) study in acute pain following bunionectomy surgery with the selective NaV1.8 inhibitor VX-548 and that it expects to commence a second Phase 2 study in acute pain following abdominoplasty surgery in the coming weeks.

“Based on the favorable Phase 1 data, we are advancing this program into Phase 2 with initiation of a dose-ranging POC study in patients with acute pain after bunionectomy surgery followed quickly by a second study in patients undergoing abdominoplasty surgery. We expect to see results from the bunionectomy study by Q1 2022,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “NaV1.8 is a genetically and pharmacologically validated target and we are excited about the potential for VX-548 as a new class of effective pain treatments without the limitations of current therapies, including the addictive potential of opioids.”

The Phase 2 studies are randomized, double-blind, placebo-controlled trials that will evaluate multiple doses of VX-548 in patients with acute pain following bunionectomy surgery or abdominoplasty surgery. Both studies will also include a hydrocodone bitartrate /acetaminophen reference arm. The primary endpoint in both studies is the time-weighted Sum of the Pain Intensity Difference over the first 48 hours of treatment (SPID48).

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About VX-548
VX-548 is an oral, selective NaV1.8 inhibitor that has completed Phase 1 studies in healthy volunteers. Based on a favorable pharmacokinetic, safety and tolerability profile, it was advanced to Phase 2 studies in 2021.

NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signaling in the peripheral nervous system. NaV1.8 is a genetically validated novel target for the treatment of pain, and Vertex has previously demonstrated clinical proof-of-concept with a small molecule investigational treatment targeting NaV1.8 in multiple pain indications including acute pain, neuropathic pain and musculoskeletal pain.

Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of medicines that have the potential to provide superior relief of acute pain without the limitations of opioids, including their addictive potential. VX-548 is the most recent molecule to enter clinical development from Vertex’s portfolio of NaV1.8 inhibitors.

Source: Vertex Pharmaceuticals
Date: Jul 19, 2021


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