J&J Oral Psoriasis Drug Meets Primary Goal in Late-Stage Study

J&J JNJ announced positive data from the phase III ICONIC-TOTAL study evaluating its investigational oral peptide, icotrokinra, for the treatment of plaque psoriasis (PsO) in patients with at least moderate severity affecting sensitive areas.

The study met its primary endpoint – 57% of patients treated with the once-daily drug for 16 weeks achieved significant skin clearance compared to 6% of those who received placebo. This was measured using the Investigator’s Global Assessment (IGA), a clinical measure to assess the overall severity of a condition or disease.

More on J&J’s ICONIC-TOTAL Study Results

The study focused on patients aged 12 years and older suffering from psoriasis in difficult-to-treat areas such as the scalp, genitals, and hands/feet, which are often challenging to manage and can significantly impair a patient's quality of life.

Per J&J, 66% of patients with scalp psoriasis who received icotrokinra achieved site-specific clear or almost clear skin compared to 11% in the placebo group. In the genital psoriasis subgroup, 77% of patients treated with the drug achieved significant skin clearance versus 21% receiving placebo.

In the smaller hand/foot subgroup, 42% of treated patients achieved skin clearance compared to 26% receiving placebo.

JNJ’s Stock Performance

Year to date, shares of J&J have gained nearly 7% against the industry’s 6% decline.

Recent Developments With J&J’s Icotrokinra

Icotrokinra is being jointly developed by J&J and Protagonist Therapeutics PTGX under a license and collaboration agreement signed in 2017. Per the terms, J&J holds exclusive worldwide rights to develop the drug in phase II studies and beyond.

The ICONIC-TOTAL study is part of J&J’s late-stage ICONIC clinical program evaluating icotrokinra across PsO and psoriatic arthritis indications. Last year, the company reported top-line results from the late-stage ICONIC-LEAD study, which evaluated the drug in patients with moderate-to-severe plaque PsO. That study also achieved its primary endpoint.

More recently, J&J and Protagonist also reported new data from two phase III studies — ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 — which evaluated icotrokinra against both placebo and Bristol Myers’ BMY psoriasis drug, Sotyktu. Both studies met their primary endpoints and demonstrated the drug’s superiority over Bristol Myers’ Sotyktu.

Based on the above outperformance, J&J started the phase III ICONIC-ASCEND study — a head-to-head study comparing icotrokinra with J&J’s own blockbuster immunology drug Stelara — in patients with moderate-to-severe plaque PsO. Through icotrokinra, J&J intends to provide a more convenient treatment option for patients than Stelara, which is administered through an injection and is currently facing generic erosion in the United States.

Apart from dermatology, J&J and Protagonist are also exploring the drug’s potential in the inflammatory bowel disease (IBD) space. Earlier this year, the companies reported positive results from the phase IIb ANTHEM-UC study, which evaluated the drug in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint of clinical response across all dose groups. J&J believes that the drug has the potential to deliver peak non-risk-adjusted operational sales of $5 billion

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J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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