Roche and Genentech’s multiple sclerosis drug Ocrevus launched like a firework in 2017, achieving blockbuster status within a year while making a mark on an already crowded market with a brand-new treatment paradigm.
It became the first and only therapy approved to treat both the relapsing form of the disease and the more aggressive and debilitating primary progressive MS, significantly slowing patients’ progression of permanent physical disability.
As Genentech’s senior director of marketing for Ocrevus, Erik Lundgren was one of the architects of that drug’s launch and saw firsthand the way it changed the market.
“The treatment paradigm at the time was [to] build up to your higher efficacy therapies over time, and we didn’t think that served patients particularly well,” he said.
Now, as newly minted CEO of Immunic Therapeutics, a late-stage biotech developing therapies for neurologic diseases, Lundgren said patients are ready for the next new “era” in MS treatment, one that prioritizes safety and slows disease progression even more.
“The introduction of the anti-CD20s, of which ocrelizumab was the first [approved therapy], truly did transform MS,” he said. “But it’s been a decade since there was a shift in how people living with MS are treated.”
Lundgren believes the next wave will include Immunic’s lead asset vidofludimus calcium, a potential first-in-class oral therapy that’s on track to read out data from two phase 3 trials in relapsing MS by late 2026.
Clinical studies have yielded encouraging safety and tolerability data, while early findings suggest the drug could help reduce relapses and slow disability progression. Those potential benefits still need to be established in pivotal trials.
At last week’s MSToronto2026 meeting, Immunic presented additional exploratory data from the phase 2 Calliper extension study suggesting a potential benefit in slowing disability progression. However, the original trial missed its primary endpoint of reducing whole-brain volume loss.
“It’s been a decade since there was a shift in how people living with MS are treated.”
Erik Lundgren
CEO, Immunic Therapeutics
The drug has also demonstrated anti-EBV activity in preclinical research. The virus has been strongly linked to MS, with a landmark study finding a 32-fold increase in disease risk after infection, although whether the drug's antiviral activity translates into clinical benefits remains uncertain.
A challenging disease to treat
After nearly two decades at Roche/Genentech, Lundgren stepped in as Immunic’s CEO in May to help the company shift from a clinical- to commercial-stage operation. But his new role feels familiar, and not only because he started work on Ocrevus before phase 3 data was available.
“What feels most familiar is this general sentiment [that] MS is crowded and it’s largely addressed. I heard that so many times 10 years ago, and I hear it again today,” he said.
With over 20 MS drugs on the market and more than 80 in development, it’s hard to argue with the “crowded” part of that sentiment. Still, drugs in the MS treatment landscape have come with a host of challenges since the first received FDA approval in 1993.
Some MS drugs, including Biogen’s Tysabri, are associated with the often-fatal brain disease progressive multifocal leukoencephalopathy. Others come with side effects that require regular monitoring of heart or kidney function, which is burdensome for both patients and physicians.
Many drugs in the current pipeline have experienced challenges, too. In December, the FDA rejected Sanofi’s non-relapsing secondary progressive MS candidate, tolebrutinib, citing the drug’s potentially fatal liver risks. Roche’s fenebrutinib, another BTK inhibitor currently under FDA priority review, has also been associated with elevated liver enzymes in clinical trials, although Roche has characterized its overall safety profile as manageable.
Moving the goalpost
There is also still a lot more work to be done in terms of disease progression, which Lundgren saw firsthand when he visited an MS thought leader’s clinic in Texas last year.
“She said, 10 years ago, this MS clinic was full of people in wheelchairs, and now it’s not,” he said. “All of the people in this room, for the most part, haven’t had a relapse in the last five or six years. There’s not even really a blip on their MRI.”
Even so, her patients were “getting worse.” Some were dealing with cognitive loss. Others who used to be able to run a 5K now can’t walk a half mile without getting winded.
“They’re chronically fatigued. They don’t feel like they’ve really beaten back this disease,” he said. “That was the a-ha moment. There’s a lot more work to be done here.”
Lundgren said that vidofludimus calcium is “really built for where MS care today is still falling short.”
“It’s an oral pill, once a day, fits into people’s lives really easily. It has, to date, a safety and tolerability profile that I think is extraordinarily unique,” he said.
He also highlighted that vidofludimus calcium works not only to tame relapses, but to slow disease progression by targeting the neurodegenerative component of the disease process.
“That’s the piece, I think, that gives us a really interesting and promising opportunity,” he said.
