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Vertex’s Suzetrigine Disappoints In Phase II Pain Study, But Phase III Planning Under Way

Acute Pain Approval Decision Due 30 January

 
• By Mandy Jackson

The NaV1.8 inhibitor showed a statistically significant change from baseline in lumbosacral radiculopathy pain, but it was the same as the reduction in the study’s placebo arm.

Lumbosacral radiculopathy is key to a larger peripheral neuropathic pain indication (Shutterstock)

Vertex Pharmaceuticals is awaiting a US Food and Drug Administration approval decision by 30 January for suzetrigine (VX-548) in the treatment of acute pain, but the blockbuster potential of the closely watched NaV1.8 inhibitor may rest largely on its ability to treat chronic pain. However, suzetrigine delivered disappointing Phase II results on 19 December in chronic treatment of lumbosacral radiculopathy (LSR) pain, although planning still is under way for a Phase III LSR program.

Vertex Stands Ready To Launch First Drug In Its Pain Franchise

NaV Channel Research Has Been A Long Journey: Vertex may win US FDA approval in January for the first novel pain drug in decades, after investing a lot of time and inventing new technology to unravel the science behind suzetrigine.

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J&J’s Trispecific Antibody For Myeloma Offers Improved Safety, Potency Over Bispecifics

 
• By Alaric DeArment

The drugmaker presented data from its Phase I study of JNJ-79635322 at ASCO and EHA showing a 100% response rate in BCMA- and GPRC5D-naïve patients.

ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By Kevin Grogan

Oral RNA splicing modulator has gone into a Phase II/III trial

Scholar Rock Shows Muscle-Building PoC In Obesity

 
• By Jessica Merrill

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

More from Scrip

China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 
• By Mandy Jackson, Joseph Haas, and Sarah Karlin-Smith

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.