Vertex Pharmaceuticals has hit a snag in its efforts to follow up non-opioid pain reliever Journavx (suzetrigine). The Boston-based big biotech’s sodium channel inhibitor VX-993 failed to outpace placebo at improving pain scores in a phase 2 trial, Vertex announced after market close on Aug. 4.
The double-blind, placebo-controlled study enrolled 367 patients who underwent bunion removal surgery. The trial tested three oral doses of VX-993 and evaluated their ability to reduce acute pain compared to placebo.
All three doses failed to improve pain intensity over a 48-hour period. As a result, Vertex is no longer pursuing VX-993 as a monotherapy for acute pain, the company said in the release.
The safety profile of VX-993 was similar to placebo, with the most common adverse events being nausea, dizziness, headache and vomiting, according to Vertex.
Patients in each treatment arm were given a large dose of VX-993 after surgery followed by a smaller dose every 12 hours after. The dose groups were 180/90 mg, 70/35 mg and 10/5 mg.
“This proof-of-concept study was powered to test whether VX-993 would result in higher clinical efficacy than previously demonstrated with the NaV1.8 pathway,” Carmen Bozic, M.D., Vertex’s chief medical officer, said in the release. “Based on these results, as well as the totality of preclinical data and results from our previous bunionectomy clinical studies, VX-993 is not expected to be superior to our existing NaV1.8 inhibitors.”
VX-993 is also being tested for diabetic peripheral neuropathy, a form of chronic pain, in a phase 2 trial that aims to enroll around 300 patients.
VX-993 is designed to serve as a next-gen inhibitor of the Nav1.8 sodium channel, part of a pathway in the peripheral nervous system that sends pain signals to the brain. It’s the same channel targeted by Journavx, which was approved by the FDA for moderate to acute pain at the end of January.
The announcement of VX-993’s fail came on the same day that Vertex presented its second quarter earnings, reporting total revenue of $2.96 billion, up 12% from last year. However, the VX-993 fail and the company’s revelation that the FDA isn’t inclined to grant Journavx a broad approval for peripheral neuropathic pain left analysts with mixed impressions.
“We expect VRTX shares to be under pressure,” analysts from Citi Research wrote in an Aug. 4 note.
Vertex also disclosed on Aug. 4 that long-time Chief Scientific Officer David Altshuler, M.D., Ph.D., plans to retire next August. Mark Bunnage, the current senior vice president of global research, will step into the CSO role on Feb. 1 as part of a planned transition.