Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate-to-severe acute pain.

The company announced its plans to submit an NDA following positive Phase III results from two clinical trials investigating the drug in patients who had undergone bunionectomy (NCT05553366) or abdominoplasty (NCT05558410) surgery. Both trials met the primary endpoints, and suzetrigine demonstrated a favourable safety profile with no serious adverse events reported. Vertex has started the rolling submission process and aims to finish by Q2 2024.

With FDA fast track and breakthrough therapy designations already secured for the drug to treat acute pain, Vertex is now focusing on neuropathic pain, where positive Phase II results have been achieved. Following a successful end-of-Phase II meeting with the FDA, Vertex is planning a Phase III pivotal programme for patients with diabetic peripheral neuropathy (DPN) later on in 2024. This is aided by the recent breakthrough therapy designation given to the drug for DPN-associated pain.

The Phase III DPN-associated pain programme will include two placebo-controlled studies each enrolling 1100 patients with DPN. The primary endpoint for both studies will be the change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) assessed at Week 12, compared to placebo.

Suzetrigine is a non-opioid painkiller that targets the sodium channel protein type 10 subunit alpha gene. It encodes NaV1.8, a sodium ion channel subtype that is involved in acute inflammatory pain. According to a GlobalData’s Pharma Intelligence Center, suzetrigine is forecast to generate $1.4bn in global sales in 2030.

In the announcement accompanying the advancements, chief medical officer at Vertex Carmen Bozic said: “Given the favourable benefit/risk profile demonstrated by suzetrigine across the entire clinical program and the positive interactions with regulators, we are excited by the opportunity to rapidly advance suzetrigine, a new non-opioid potential treatment, for the millions of patients suffering from acute and peripheral neuropathic pain.”

It’s not just pain management that Vertex is focused on. Earlier this month, the company acquired biotech Alpine Immune Sciences for $4.9bn, meaning it is ramping up activities in the immunotherapy space. Alpine’s lead asset, povetacicept, is set to enter Phase III trials in the second half of 2024. The dual agonist drug is being developed for renal indications and autoimmune cytopenias.

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