Guselkumab

Johnson & Johnson’s much-hyped Icotyde pill shows another biologic-like efficacy in inflammatory diseases, with a phase 3 win tying the oral peptide to improved symptoms in patients with psoriatic arthritis. Icotyde delivered “competitive joint efficacy, strong skin responses and a clean safety profile” in psoriatic arthritis patients who had not received a biologic drug, Jefferies analyst Roger Song, M.D., described in a Nov. 8 note about J&J’s phase 3 data from the Iconic-PsA 1 trial. When dosed at 200 mg once per day, significantly more patients who took Icotyde than those on placebo achieved an American College of Rheumatology 20 (ACR20) response, a composite endpoint representing at least a 20% improvement in certain disease symptoms. The rates were 58% versus 41%, respectively, at week 16, according to results presented at ACR Convergence 2026. Icotyde 200 mg also did better on ACR50 (29% vs. 16%) and ACR70 (13% vs. 5%). And the IL-23 receptor antagonist’s response rates increased over time, as ACR20, ACR50 and ACR70 response rates reached 69%, 40% and 18%, respectively, through week 24. The drug’s efficacy appears similar to biologics by cross-trial comparison. For example, J&J’s own blockbuster anti-IL-23 biologic Tremfya recorded 64% ACR20, 31% ACR50 and 19% ACR70 at week 24 in its own trial in biologic-naïve patients. These strong data were stained by one disappointment. When dosed with 400 mg Icotyde, 52% of patients achieved ACR20, with its comparison with the placebo landing at a p-value of 0.052, narrowly missing statistical significance . The trial design requires both doses to be statistically significant on the primary endpoint to formally test for secondary endpoints. In addition, strong placebo responses also made Icotyde’s placebo-adjusted efficacy look unfavorable compared with existing biologics. For example, at week 16, Icotyde’s efficacy advantage over placebo was 17, 13 and 8 percentage points on ACR 20, ACR50 and ACR70; while Tremfya’s data in its own trial was 31, 17 and 15 percentage points, respectively, at week 24. Nevertheless, Jefferies’ Song said that his team is “not concerned given the consistently strong 200mg performance reaching competitive efficacy and [a] favorable overall profile.” In addition to the ACR responses that mostly focus on joint health, Icotyde also achieved skin responses that Song labeled “particularly strong.” Among patients whose psoriasis was serious enough to reach a body surface area of 3% and an investigator’s global assessment (IGA) score of 2, 57% receiving Icotyde achieved clear or almost clear skin with an IGA score of 0 or 1. Only 14% receiving placebo could say the same. Statistically, the finding again only bears nominal significance because of the 400-mg miss on the primary endpoint. Regarding safety, Song described Icotyde’s profile as “clean” with no new signals. Through week 24, serious adverse events were only recorded in 1% of patients in the Icotyde 200-mg group and 3% in the 400-mg group, versus 7% in the placebo arm. “The data reinforce our thesis that Icotyde can pair biologic-like efficacy with oral convenience, supporting [psoriatic arthritis expansion] and the broader multi-indication franchise opportunity,” Song wrote in his Nov. 8 note. “Many people living with psoriatic arthritis are still searching for treatments that can effectively address the full burden of their disease,” David Lee, M.D., Ph.D., J&J’s global immunology therapeutic area head, said in a statement. “These new findings underscore the potential of Icotyde to meaningfully improve outcomes in psoriatic arthritis and add to the growing body of evidence across psoriatic disease.” Icotyde got its initial FDA approval in March for the treatment of plaque psoriasis. It was touted as a game-changer because of its strong, biologic-level efficacy and relatively clean safety profile that comes in the form of a daily pill. J&J foresees Icotyde to be one of its biggest pharmaceutical assets, Tom Cavanaugh, J&J’s new innovative medicines chief, said on the company’s third-quarter earnings call last month. There’s a clear demand for an effective, well-tolerated pill, particularly among younger, injection-averse patients, a rheumatology KOL told Jefferies, according to a separate Nov. 8 note penned by Jefferies’ Song. The expert views Icotyde’s latest phase 3 data favorably. But strong efficacy data from injectable IL-17 inhibitors such as Novartis’ Cosentyx and UCB’s Bimzelx and a growing number of oral TYK2 inhibitors like Takeda’s near-market zasocitinib represent fierce competitors to the J&J drug. As Leerink analysts pointed out in their Nov. 8 note, IL-23 agents like Tremfya “have historically lacked depth of response in [psoriatic arthritis] and, as a result, have been less utilized than IL-17 and anti-TNF therapies.” In psoriatic arthritis, J&J is running another phase 3 trial, Iconic-PsA 2, which enrolls both biologic-naïve and -experienced patients, with a readout expected in first-half 2027.