Cancer drug research continues to bring patients targeted therapies for tumors that express specific genetic or biological signatures. This precision oncology approach means a clinician can tailor treatment to a patient’s disease. Such precision medicine strategies are starting to find a place in immunology.
Martin Babler, CEO of Alumis, said his company’s research into the genomics of autoimmune disease gives it a better understanding of what’s happening in the body. That understanding could help inform a clinician which patients may respond to a particular drug. Some of those drugs could come from Alumis.
“Ultimately our goal is to have precise therapy, so that patients feel like, if I take this drug, I’m really going to benefit from it,” Babler said in an interview during the J.P. Morgan Healthcare Conference in January. “As a company, we’re basically founded on the principle of precision immunology — how can we find the right drug for the right patient at the right time that has a narrow enough set of targets that it hits so the patient really gets mostly the benefit and doesn’t have to suffer a lot of side effects.”
Alumis’s lead program, envudeucitinib, is in late-stage clinical development for plaque psoriasis. The drug is an oral small molecule designed to block TYK2, a protein that plays a role in inflammation. After reporting positive preliminary Phase 3 results early this year, Alumis was able to raise more than $345 million in a stock offering. Clinicians and investors have been awaiting more detailed data. Those results are included as a late-breaker presentation scheduled for this Saturday during the annual meeting of the American Academy of Dermatology in Denver. Alumis will hold a Sunday conference call to discuss the data.
Emergence of Oral Drugs for Psoriasis
When patients need something stronger than a topical drug to treat plaque psoriasis, the next line of therapies had been injectable biologic drugs. Bristol Myers Squibb gave patients an oral alternative with Sotyktu, which became the first TYK2 inhibitor to reach the market following its 2022 FDA approval.
While the market for psoriasis drugs is crowded between topicals and injectables, companies have been trying to fill the space between them with oral drugs, a formulation that many patients prefer. Last week, Johnson & Johnson received FDA approval for Icotyde, an oral peptide that targets the IL-23 receptor to treat plaque psoriasis. J&J projects this pill could top $5 billion in peak revenue across multiple indications. As for Sotyktu, the BMS drug has not become a big seller, tallying $291 million in 2025 revenue. Alumis is part of a group of biopharmaceutical companies developing TYK2 inhibitors intended to offer better safety and efficacy than BMS’s once-daily pill.
Alumis’s genetic studies showed that a drug needs to hit TYK2 really hard, meaning that over the course of the day, the molecule needs to have more than 90% coverage of the target, Babler said. TYK2 is found throughout the body, so there needs to be sufficient levels of a drug in circulation to block enough of those proteins. Without more than 90% coverage of TYK2, the proteins that aren’t blocked still send signals that trigger inflammation, so a drug does not achieve the desired therapeutic effect.
“Where we are different from all the other TYK2 inhibitors is we’ve figured out a way to be above 90% coverage of TYK2 for 24 hours in patients,” Babler said. “At the same time, though, you don’t want to push it too high, because if you push it too high, you get side effects.”
In January, Alumis reported envudeucitinib achieved statistically significant skin clearance in two Phase 3 studies. Results at 24 weeks showed that about 65% of patients achieved 90% or greater clearance according to a scale used to assess psoriasis severity. More than 40% achieved complete skin clearance — a functional cure. That, Babler said, has not been accomplished by any other plaque psoriasis drug. Babler said the results go beyond skin clearance. One of the manifestations of plaque psoriasis is severe itching. Babler said envudeucitinib’s results showed a strong reduction in itch and improvement in quality of life that Alumis believes will differentiate it from others in its class.
Takeda Pharmaceutical’s zasocitinib is one of those drugs. Late last year, Takeda reported preliminary Phase 3 results showing more than half of patients achieved clear or near-clear skin at week 16 and those responses increased through week 24. Andy Plump, Takeda’s president, research and development, previously told MedCity News that zasocitinib’s advantage is achieving close to complete inhibition of TYK2 over a 24-hour period with a once-daily pill.
The twice-daily dosing of Alumis’s drug is bit less convenient for patients. Babler said the two pills a day are needed to cover more than 90% of TYK2 receptors for 24 hours. Alumis is also developing a once-daily version of its drug, but that formulation is still being optimized.
“Other people optimized for convenience, but maybe didn’t optimize for safety and efficacy at the same level as we did,” Babler said. “That’s really the piece that we believe that will differentiate our molecules from others. We’ll optimize for convenience later with a separate formulation. Our first goal was to optimize for safety and efficacy.”
Next Up for Alumis: Lupus
The role that TYK2 plays in inflammation is associated with many autoimmune conditions. Lupus is the second disease target for envudeucitinib; results from a Phase 2b study are expected this summer. Babler said envudeucitinib could address about 20 different indications, but Alumis won’t go after all of them. For some disorders, it might make more sense to work with a partner. Babler added that the recent financing buys the company time to wait until at least after the lupus study readout before making partnering decisions.
Leerink Partners views envudeucitinib as best in class. In a recent research note, Leerink analyst Thomas Smith said the properties of Alumis’s drug make it superior at blocking TYK2 with better inhibitory coverage. He added that the positive Phase 3 results in plaque psoriasis partially de-risk the upcoming mid-stage readout in lupus.
Research has also shown TYK2 plays a role in neurological disorders, so Alumis developed a second TYK2 inhibitor with the ability to penetrate the brain. This drug has potential applications in Alzheimer’s and Parkinson’s disease, but its first neuro test will be a proof-of-concept clinical trial in multiple sclerosis.
For the indications Alumis pursues, Babler said the company is taking a precision immunology approach. In some diseases, such as psoriasis, the main driver of the disorder is defined. But for others, such as lupus, there are multiple drivers. In other diseases, it’s not clear what the main driver or drivers are. Babler said the goal is be able to characterize patients to assess whether a particular therapy would be appropriate for what’s driving their disease. The idea is to narrow down what the most efficacious therapy would be for a given patient or group of patients.
“Right now, a lot of these patients take drugs and it works for maybe half of the patients or two-thirds,” Babler said of lupus medicines. “The others still have to take the drug, [but] don’t necessarily get a benefit. If we could improve that ratio, that is really the goal of precision.”
Photo by Flickr user FutUndBeidl via a Creative Commons license
