Argenx touts Vision 2030 as Vyvgart homes in on next potential indication

2024-06-17

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Argenx touts Vision 2030 as Vyvgart homes in on next potential indication

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来源: FiercePharma

As of early May, there were more than 10,000 patients on Vyvgart around the world.

As argenx homes in on the next indication for its pipeline-in-a-product Vyvgart (efgartigimod), the company is preparing for the next leg of its commercial journey.

Next month, on July 16, argenx will host an R&D day, during which the company will unveil its new program dubbed Vision 2030: Taking Breakthrough Science to 50,000 patients.

As part of Vision 2030, argenx will touch on its continuing commitment to tackle severe autoimmune diseases with Vyvgart, which won its first approval in generalized myasthenia gravis (gMG) in late 2021.

The company also plans to highlight its next potential commercial product empasiprubart—an antibody designed to inhibit the C2 protein that’s in early testing for multifocal motor neuropathy (MMN) and other diseases—as well as its broader antibody-based pipeline.

With Vyvgart in particular, argenx aims to highlight its plans to broaden the drug’s foothold in gMG, its next potential nod in chronic inflammatory demyelinating polyneuropathy (CIDP), and the company’s wider plans to move into a new wave of indications.

Additionally, argenx says it plans to “invest in its organic innovation engine to bring forward new first-in-class pipeline candidates.”

"argenx today is better positioned than ever before to deliver on our commitment to transform the autoimmunity treatment landscape for patients,” Tim Van Hauwermeiren, CEO of argenx, said in a statement. “We have grown from our R&D roots over the last five years into a true global innovator, pioneering novel targets into a robust pipeline and delivering safe and effective first-in-class medicines to more than 10,000 patients around the world.”

Taking a closer look at the company’s efgartigimod plans, argenx will talk up the potential to expand Vyvgart in MG through studies including the seronegative form of the disease.

Roughly 15% of generalized MG patients are estimated to be seronegative, which could provide a meaningful addition to the drug’s current green light, Van Hauwermeiren told Fierce during a recent interview.

Aside from myasthenia gravis, argenx will also tout results from its phase 2/3 Vyvgart study in immune-mediated myopathies, plus topline phase 2 data in Sjogren’s disease.

Over the weekend, Johnson & Johnson presented positive results on its antibody nipocalimab in patients with primary Sjogren’s disease. As a member of the same class of FcRn receptor-targeting drugs that Vyvgart belongs to, nipocalimab’s trial results “do appear to support the FcRN antagonism approach in [Sjogren’s] and argenx’s decision to advance efgartigimod into a Phase III trial based on an analysis of the results from the RHO study,” William Blair’s Matt Phipps and Myles Minter wrote in a note to clients Monday.

Argenx will also flaunt its next potential “pipeline-in-a-product” opportunity with empasiprubart, highlighting phase 2 data in MMN, as well as unveiling a preview of phase 2 studies in delayed graft function and dermatomyositis and introducing a fourth indication.

Lastly, argenx will go over how it plans to scale its global commercial footprint to support Vision 2030.

As of early May, there were more than 10,000 patients on Vyvgart around the world.

Argenx is currently marketing Vyvgart for gMG in the U.S., Canada and multiple European countries, as well as China and Japan. The company also has Vyvgart distribution deals in places like the Middle East and Eastern Europe.

Argenx will not chart any organizational changes as part of its new 2030 growth plan, a company spokesperson confirmed over email.

At the same time it teased its Vision 2030, argenx also revealed that it’s stopping the development of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) after its phase 2 ALPHA study found that treated patients had no clinically meaningful improvement compared to those on placebo on a measure of symptoms.

While the discontinuation may read negative, "we did not explicitly ascribe any value to this indication in our model," analysts at Leerink Partners wrote in a note to clients, noting they remain confident in Vyvgart's "strong commercial execution."

The company has reason to be optimistic, too, as Vyvgart nears its next potential indication in CIDP by the end of the week. The drug, which boasts positive phase 3 data in the rare autoimmune disease, is up for an FDA decision in CIDP on June 21. That new indication could represent another "multi-billion dollar commercial opportunity," the Leerink team added.

CIDP is a disease of the peripheral nervous system that causes fatigue, muscle weakness and loss of feeling in patients’ arms and legs. That weakness can worsen over time or come and go, with the potential for symptoms to significantly impair a person’s ability to function on a day-to-day basis.

If approved, Vyvgart will go up against Takeda’s subcutaneous immune globulin treatment HyQvia, which won its own CIDP nod in January.