In the fast-evolving world of immunology, the race to develop a highly effective oral treatment for psoriasis has reached a fever pitch. With the recent success of Alumis’s Phase 3 trials for envudeucitinib, the landscape is poised for a significant shift. We sat down with biopharma expert Ivan Kairatov, whose deep knowledge of technology and innovation in drug development provides a unique lens through which to view these breakthroughs. We explored the nuances of Alumis’s clinical data, the strategic chess match against established competitors and powerful injectable biologics, and the broader potential of this new class of drugs to redefine treatment for a host of autoimmune diseases.
On January 6, Alumis announced envudeucitinib achieved 74% PASI75 clearance in Phase 3 trials, causing shares to double. Could you walk us through the specific data points beyond the headline numbers that you believe gave analysts confidence that this drug has “class-leading” potential?
Absolutely, and that market reaction was truly something to see. The 74% PASI75 number is fantastic, of course—that means nearly three-quarters of patients saw their skin lesions clear by 75% in just four months. But what really ignited the excitement, I believe, were the secondary endpoints and the competitive context. The co-primary goal, a physician’s evaluation, showed that 59% of patients were rated as “clear” or “almost clear.” This isn’t just a statistical improvement; it’s a visible, life-changing result that clinicians can see with their own eyes. When you place these figures next to competitors, you see a drug that isn’t just participating, but leading. This is the kind of data that starts to close the gap with the powerful injectable biologics, and for an oral pill, that is the holy grail.
The article positions this drug against competitors from Takeda and J&J, as well as the approved drug Sotyktu. Beyond the efficacy data, what specific details about envudeucitinib’s safety profile or mechanism do you think will be most crucial for gaining market share in this competitive space?
That’s a critical point because in a chronic condition like psoriasis, patients are on these therapies for years, not weeks. Efficacy gets a drug approved, but safety and tolerability are what keep it on the market and make it a top choice. The report that envudeucitinib was “generally well tolerated” with mostly mild to moderate side effects is enormously important. We’re talking about things like headaches and congestion, not severe adverse events that require constant monitoring. This profile offers peace of mind. For a patient who might be facing a lifetime of treatment, knowing they can take a simple pill without a cloud of serious side effects hanging over them is a massive advantage. This combination of high efficacy and a clean safety record is the one-two punch that could allow it to leapfrog competitors.
Bristol Myers’ Sotyktu, the first TYK2 blocker, had sales of $126 million through the first nine months of 2025. Given these results, what is Alumis’s step-by-step strategy to convince physicians that a newer oral pill can truly challenge powerful injectable biologics like Skyrizi?
Sotyktu’s sales figures, $126 million in nine months, show that just being the first oral TYK2 isn’t enough to disrupt the market. Alumis has to execute a very different playbook. The first step is to hammer home the superiority of their data. They need to show physicians that envudeucitinib isn’t just an alternative to biologics, but a true rival in terms of efficacy. The second, and equally important, step is to lean into the patient-preference angle. The convenience of a pill over an injection is a powerful motivator for patients who are tired of needles. Finally, the strategy must involve a sophisticated educational campaign targeting dermatologists, demonstrating that this drug isn’t just for patients who have failed other therapies, but a compelling first-line option for moderate-to-severe psoriasis that can deliver biologic-level results from day one.
While the psoriasis results are impressive, the content notes that envudeucitinib is also being tested for Crohn’s and lupus. Can you elaborate on the scientific rationale for targeting these different diseases and describe any early metrics that suggest the drug’s success could be replicated?
The scientific rationale is incredibly elegant and is what makes this TYK2 class so exciting. These diseases—psoriasis, Crohn’s, lupus—all look different on the surface, but underneath, they are driven by a similar engine of chronic inflammation. TYK2 is a key signaling protein that acts like a master switch for several inflammatory pathways. By precisely blocking TYK2, you’re not just treating a symptom; you’re cutting the power to that engine. Psoriasis is often the first target because the results are so visual and easy to measure, making it a perfect proof-of-concept. The resounding success there builds tremendous confidence that the drug’s core mechanism is effective. This suggests that envudeucitinib isn’t just a psoriasis drug; it’s a potential “pipeline in a pill” that could be a transformative therapy across a range of debilitating immune disorders.
What is your forecast for the oral psoriasis treatment landscape over the next five years, especially concerning the battle between next-generation TYK2 inhibitors and established injectable biologics?
My forecast is for a dramatic reshaping of the treatment paradigm. The next five years will not be about incremental improvements; they will be about a fundamental shift in what physicians and patients expect from an oral therapy. We are moving past the era where taking a pill meant accepting a significant drop in efficacy compared to an injectable. High-performance orals like envudeucitinib will aggressively carve out market share from biologics, particularly for patients who are needle-averse or whose disease is not yet at its most severe stage. I envision the market segmenting, with these next-generation TYK2 inhibitors becoming the go-to first-line oral option for many, challenging the dominance of injectables. The ultimate winners will be the patients, who will have powerful, convenient, and well-tolerated options that were simply not available a decade ago.
