Alumis's Oral Drug Shows Unprecedented Psoriasis Clearance in New Data

SOUTH SAN FRANCISCO, Calif. – August 10, 2026 – In a development that could significantly alter the treatment landscape for millions suffering from plaque psoriasis, Alumis Inc. today announced remarkable long-term data for its investigational oral therapy, envudeucitinib. The results from the ONWARD3 extension study show that after 48 weeks of continuous treatment, 54% of patients achieved completely clear skin—a benchmark known as PASI 100. This figure represents the highest reported rate of complete clearance for any oral therapy in this disease, positioning the late-stage biopharmaceutical company to challenge both established pills and injectable biologics.

The data confirms not only high efficacy but also durable responses and a consistent long-term safety profile, providing a powerful combination that physicians and patients have long sought. With plans to file for FDA approval later this year, Alumis is poised to move from a promising clinical-stage firm to a major commercial player in the competitive immunology market.

Redefining the Standard for Oral Therapy

For years, patients with moderate-to-severe plaque psoriasis have faced a trade-off: the high efficacy of injectable biologics or the convenience of oral medications, which have historically offered more modest results. Envudeucitinib appears to shatter that compromise. The topline results from the ONWARD3 long-term extension study are striking: besides the 54% of patients achieving complete skin clearance (PASI 100), 75% achieved a 90% improvement (PASI 90).

These numbers place envudeucitinib in a class of its own among oral treatments. For context, the first-in-class oral TYK2 inhibitor, Bristol Myers Squibb's Sotyktu (deucravacitinib), showed PASI 100 rates of around 15% at 24 weeks in its pivotal trials. The long-standing oral option, Amgen's Otezla (apremilast), has reported PASI 100 rates of approximately 10% after a year of treatment. In its own head-to-head trials, envudeucitinib demonstrated clear superiority over Otezla. The durability of the response is equally impressive, with the study showing that approximately 80% of patients who achieved complete clearance maintained it through the duration of the extension.

“Far too many people with psoriasis remain undertreated or untreated, and without meaningful skin clearance, this systemic disease continues to limit daily life,” said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. “We are excited for the potential of a new oral therapy that may offer the sustained control patients need to get back to living fully. Restoring those everyday moments is part of what real progress looks like.”

The convenience of a daily pill cannot be overstated. It eliminates the need for injections, clinic visits, and the potential for injection-site reactions, which can be significant barriers to adherence. By offering efficacy that begins to rival some injectable biologics in an oral form, Alumis could capture a significant segment of the market, including patients who are needle-averse or those for whom current oral options have been insufficient.

The Science of Precision Inhibition

Envudeucitinib belongs to a highly promising class of drugs known as TYK2 inhibitors. Tyrosine kinase 2 (TYK2) is a critical enzyme in the signaling pathways of several cytokines—including IL-23, IL-17, and Type I interferons—that drive the inflammation underlying numerous autoimmune diseases. By blocking TYK2, these drugs can effectively quiet the overactive immune response.

The key to envudeucitinib's profile lies in its design. Alumis describes it as a “next-generation” inhibitor, “precision-engineered for maximal 24-hour target inhibition.” This selective, allosteric approach allows it to potently block the TYK2 pathway while minimizing effects on other related enzymes in the JAK family, a distinction that is crucial for its favorable safety profile. Broader-acting JAK inhibitors have been associated with more significant safety concerns, leading to black box warnings from the FDA.

The long-term ONWARD3 data reinforced this safety advantage, with a tolerability profile that remained consistent with earlier trials and no new safety signals emerging after nearly a year of treatment. This long-term reassurance is critical for any drug intended for chronic use.

“Envudeucitinib delivered consistently high rates of skin clearance in the Phase 3 trials, and the long-term data show that the vast majority of patients maintained these strong responses through 48 weeks, with the number of patients achieving completely clear skin continuing to rise over time,” said Dr. Mark Lebwohl, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai. “These data, coupled with a consistent safety profile, suggest that envudeucitinib can deliver the durable, reliable disease control physicians and patients are seeking from an oral therapy.”

A 'Pipeline-in-a-Pill' and Alumis's Strategic Ascent

The strong performance in psoriasis is likely just the beginning for envudeucitinib and Alumis. The company is strategically positioning the drug as a 'pipeline-in-a-pill,' leveraging the central role of TYK2 in a wide array of immune-mediated conditions. Success in one disease validates the mechanism and de-risks development in others.

All eyes are now on the upcoming data from the LUMUS Phase 2b trial evaluating envudeucitinib in systemic lupus erythematosus (SLE), expected in the third quarter of 2026. A positive result in lupus, a notoriously difficult-to-treat autoimmune disease, would dramatically expand the drug's market potential and cement Alumis's status as a major innovator in immunology.

“These long-term data, including the robust 54% PASI 100 response, further validate the strength of envudeucitinib’s precision-engineered design for continuous, maximal TYK2 inhibition and underscore its highly competitive clinical profile,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. He noted that the performance reinforces the drug’s potential to become a leading oral therapy for psoriasis and a foundational treatment for other diseases driven by the same inflammatory pathways.

With a New Drug Application (NDA) submission to the FDA planned for the fourth quarter of this year, Alumis is on a clear path to commercialization. The precedent set by Sotyktu's approval provides a defined regulatory pathway, and the strength of the ONWARD data package suggests a high probability of success. Should it gain approval, envudeucitinib will enter a dynamic but lucrative market, ready to compete not just on convenience but, for the first time in the oral category, on truly top-tier efficacy.