Johnson & Johnson to Conduct Phase 3 Trial to Stay Competitive in the Pursuit of Oral Psoriasis Medications

Johnson & Johnson (J&J) is making progress in developing a pill formulation to treat plaque psoriasis, a skin disorder that is currently treated with injectable biologic drugs. The company presented mid-stage data for its experimental drug JNJ-2113 at the World Congress of Dermatology meeting in Singapore. The study showed that a higher proportion of patients treated with JNJ-2113 achieved a 75% improvement in their condition compared to a placebo. J&J plans to advance the drug candidate to Phase 3 testing. JNJ-2113 is designed to block interleukin-23 (IL-23), a protein that plays a role in inflammatory conditions, including psoriasis. J&J currently markets two biologic drugs that target IL-23 to treat psoriasis.
The Phase 2b study for JNJ-2113 enrolled 255 patients with moderate-to-severe plaque psoriasis, who were randomly assigned to receive different doses of the experimental therapy or a placebo. The best results were seen in the twice-daily 100 mg dose group, where 78.6% of participants achieved the main goal of a 75% improvement (PASI 75). This dose also led to the best responses in secondary endpoints, with 59.5% of participants achieving a 90% improvement (PASI 90) and 40.5% achieving a 100% improvement (PASI 100). J&J said the drug was well tolerated, with adverse events comparable across all treatment groups. The most common complications were infections and infestations.
The development of an oral therapy for psoriasis could provide greater ease and convenience for patients, potentially leading to increased adoption of advanced treatment options. J&J’s drug candidate offers an alternative to the current injectable biologic drugs, which have been the mainstay of treatment for psoriasis. Other companies, including Bristol Myers Squibb and Takeda Pharmaceutical, are also developing oral treatments for psoriasis targeting different pathways involved in the disease.
JNJ-2113 originated from Protagonist Therapeutics and is part of a research partnership with J&J’s subsidiary, Janssen Biotech. Janssen has taken the lead in the development of IL-23 programs, including JNJ-2113. Protagonist is eligible for milestone payments up to $900 million as part of the partnership. In comparison to other oral psoriasis drugs, JNJ-2113 shows promising efficacy, with a higher proportion of patients achieving PASI 75 compared to Bristol Myers Squibb’s Sotyktu and Takeda’s TAK-279 in their respective Phase 3 trials.
In addition to IL-23, other targets such as TYK2 and IL-17 are being pursued by companies like Takeda Pharmaceutical, Ventyx Therapeutics, and Dice Therapeutics. These oral therapies provide additional treatment options for patients with plaque psoriasis and offer potential benefits in terms of convenience and ease of use. The development of these oral drugs represents a significant advancement in the treatment of this chronic skin condition.