Vertex is smarting from a pain portfolio setback
Vertex Pharma’s chief executive Reshma Kewalramani.
Shares in Vertex Pharma have come under pressure after one of its non-opioid pain candidates failed to move the needle in a mid-stage trial.
Patients undergoing bunionectomy surgery did not see a statistically significant improvement in pain levels with the selective NaV1.8 inhibitor compared to placebo in the phase 2 dose-ranging trial, prompting Vertex to end development of the drug as a monotherapy for acute pain indications.
Vertex already has one NaV1.8 drug on the market – Journavx (suzetrigine), which was cleared for acute pain in February – but had hoped to improve on the clinical profile of that drug with VX-993.
"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," said Carmen Bozic, Vertex's chief medical officer.
"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," she added.
The outcome of the study was just one setback reported by Vertex as it updated investors on its second-quarter results, alongside the revelation that the FDA does not see a path to approval for suzetrigine in peripheral neuropathic pain (PNP), which is central to the company's hopes of expanding use of the drug into chronic pain settings.
Earlier this year, the company also reported disappointing results with suzetrigine in lumbosacral radiculopathy (LSR) or sciatica, another form of neuropathic pain, which dented optimism about its prospects. Now, it has confirmed it will also not be conducting another LSR trial based on feedback from the FDA.
Chronic pain is a much larger potential market for Journavx than use of the drug in short-term, acute treatment settings.
"While a broad PNP label remains our goal, at this time, the FDA does not see a path to a broad indication," Vertex chief executive Reshma Kewalramani told analysts on the company's results call.
"In light of the discussions and clear agreement with the FDA regarding approval requirements for diabetic peripheral neuropathy or DPN, we will begin a second DPN phase 3 study shortly in order to secure DPN as our first PNP indication for suzetrigine," she added. The goal is to complete both DPN trials by the end of 2026.
Shares in Vertex were trading down almost 12% at the time of writing.
