Johnson & Johnson reports at least 72% PASI 90 after two years
ICONIC-LEAD's two-year skin clearance results set a longer follow-up point for Alumis's investigational oral psoriasis drug.
Adrian Kessler
PASI 90 response rates stayed at or above 72 per cent through week 112 as Johnson & Johnson NYSEJNJ reported new results for its oral psoriasis drug ICOTYDE on Friday. From week 64 onward, at least 70 per cent of treated participants also had clear or almost clear skin, according to the company's Oct. 9 release.
The Phase 3 ICONIC-LEAD trial enrolled 684 adults and adolescents with moderate-to-severe plaque psoriasis. J&J initially assigned 456 participants to ICOTYDE and 228 to placebo, then followed treatment and withdrawal responses beyond the original controlled period.
ICOTYDE is J&J's oral peptide that blocks the interleukin-23 receptor. J&J shares NYSEJNJ rose 0.40 per cent to US$257.50 at 9:35 a.m. EDT Friday on the NYSE.
Alumis Has a Shorter Follow-Up Window
Alumis Inc. NASDAQALMS is a South San Francisco developer testing the oral TYK2 inhibitor envudeucitinib for the same disease. Its planned U.S. drug application in the fourth quarter of 2026 makes J&J's longer follow-up relevant to the evidence investors will weigh around that filing.
Alumis's Aug. 10 extension update analyzed 773 continuously treated participants using non-responder imputation. At week 48, 75 per cent achieved PASI 90. A broader analysis of 890 originally randomized patients, including those who did not enter the extension, found 66 per cent achieved PASI 90 at week 48.
The original ONWARD trials offer controlled results at an earlier point. Alumis's March 28 report gives the figures for each arm. In ONWARD1, 59.9 per cent on envudeucitinib achieved PASI 90 at week 16. The placebo rate was 4.8 per cent. ONWARD2 reported 53.1 per cent against 4.3 per cent, while the trials' co-primary endpoints were PASI 75 and clear or almost clear skin by physician assessment.
The J&J and Alumis percentages measure different patients at different times, with different treatment and withdrawal rules. They show the durability standard facing an investigational oral drug; they do not establish which product performs better in a head-to-head trial.
Read more: Alumis reports 48-week scalp and itch data from Phase 3 psoriasis program
The broader biotechnology sector was higher at the opening: the iShares Biotechnology ETF NASDAQIBB traded at US$202.70, up 1.11 per cent, at 9:33 a.m. EDT Friday on Nasdaq.
Placebo Treatment Ended Before the Two-Year Measure
The ICONIC-LEAD registry record, updated Sept. 28, lists PASI 90 and a physician score of clear or almost clear skin at week 16 as the co-primary endpoints. Participants initially given placebo crossed to ICOTYDE after week 16. Some adults responding at week 24 were then assigned to treatment withdrawal or continuation, and the registry says all adults received ICOTYDE from week 52.
From weeks 64 to 112, at least 44 per cent achieved PASI 100. At least 46 per cent had completely clear skin by physician assessment. J&J also said 85 per cent of week-24 PASI 90 responders who stopped treatment regained that response within 24 weeks of retreatment. Those later percentages have no concurrent original placebo comparison or reported p value in the release.
Safety findings through week 112 were consistent with ICOTYDE's established profile, with no new signals identified, J&J said. The company did not give adverse-event counts for this follow-up in its summary.
"With two-year data that show long-term skin clearance and a consistent safety profile, ICOTYDE is transforming how we think about plaque psoriasis treatment," study investigator Mark Lebwohl said in the Oct. 9 release. J&J identifies him as a paid consultant.
The registry estimates ICONIC-LEAD will complete on April 6, 2027. Its week-112 report is therefore an interim durability account, and J&J's release does not report FDA design feedback for that analysis.
Alumis plans to submit its psoriasis application to the FDA in the fourth quarter of 2026, which ends Dec. 31. That filing will test whether the company can put its Phase 3 package before regulators on schedule as J&J adds longer oral-treatment data.
