Alms (ALMS) new drug for psoriasis, with a maximum PASI90 of 59.9% in Phase 3 clinical trials... will change the landscape of oral treatment.

American biotech company Alumis (ALMS) announced the results of its Phase III clinical trials for the next-generation psoriasis treatment “enbuducitinib,” indicating a potential shift in the treatment landscape for moderate to severe plaque psoriasis. The drug has demonstrated significant efficacy in improving skin conditions and enhancing quality of life, being evaluated as competitive compared to existing oral therapies.

On the 28th (local time), Alumis (ALMS) presented the results of the global Phase III clinical trials “ONWARD1” and “ONWARD2” for enbuducitinib at the American Academy of Dermatology (AAD) annual meeting. Enbuducitinib is a selective TYK2 inhibitor that inhibits the inflammatory response of plaque psoriasis by blocking the immune signaling pathways IL-23/IL-17 as an “oral treatment drug.”

The clinical trial results showed that the proportion of patients reaching the PASI 90 standard by week 16 was 59.9% and 53.1%, respectively, demonstrating overwhelming improvement compared to the placebo group (around 4%). By week 24, this proportion peaked at 68%, indicating a sustained trend of enhanced treatment effects. This means that the PASI 100 indicator, which signifies complete skin improvement, also reached a maximum of 41% by week 24.

Significant improvements were also confirmed in difficult areas such as scalp psoriasis. By week 24, about 75% of patients achieved “almost clear” status or better, with some patients showing responses after just 4 weeks of treatment. Industry experts commented, “The ability to quickly improve in difficult treatment areas holds important clinical significance.”

Quality of life indicators also confirmed positive changes. By week 12, about half of the patients achieved a Dermatology Life Quality Index (DLQI) score of 0-1, with itching symptoms beginning to improve after 2 weeks of treatment. Given that symptoms perceived by patients were alleviated early, this is viewed as a “differentiated competitive advantage.”

Concerns about safety were also relatively limited. Mild adverse reactions such as headaches and nasopharyngitis were predominant, with no reports of serious side effects or cases of tuberculosis reactivation. The company explained that this aligns with the safety profile observed in previous Phase II clinical trials.

Dr. Andrew Blauvelt, an authoritative expert in psoriasis treatment, remarked, “The speed of symptom relief perceived by patients and the depth of treatment effects are impressive,” and pointed out that “it is noteworthy that such a level of skin improvement and symptom relief can occur simultaneously among oral treatment drugs.”

Dr. Jørn DeLapa, Chief Medical Officer of Alumis, emphasized, “Enbuducitinib is a case where the long-term promise of the TYK2 mechanism has been validated in practice,” adding, “Through continuous targeted inhibition over 24 hours, it enhances ‘clinical completeness.’”

Alumis is currently conducting additional validation of sustained effects and safety through the long-term extension trial ONWARD3 and plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) in the second half of 2026.

The market is paying attention to enbuducitinib as it is expected to become the “new standard” for the treatment of plaque psoriasis. Analysts believe that this drug, with its faster onset, higher remission rates, and safety assurance compared to existing therapies, has the potential to reshape the competitive landscape of the oral treatment drug market.