Johnson & Johnson Submits NDA for Icotrokinra (JNJ-2113), the World’s First Oral IL-23 Receptor Antagonist Peptide, for Moderate-to-Severe Plaque Psoriasis

First TargetedIL-23Oral peptide drugs may be launched soon!

2025Year7Month21Day, Johnson & Johnson andProtagonist TherapeuticsAnnounced that it has submitted to the United StatesFDASubmitNDA, seeking approval for its once-daily oral peptide therapyicotrokinra（JNJ-2113) marketed, for the treatment of12Years and above with moderate to severe plaque psoriasis (PsO) Adult and pediatric patients.

JNJ-2113YesThe World's First OralIL-23Receptor Antagonist`, the original research is`Protagonist。2021Year, Johnson & Johnson9.8Total transaction price in billions of US dollars fromProtagonistTwo models have been obtained.IL-23Global rights of the product under research,JNJ-2113is one of them.

It can be foreseen,JNJ-2113The listing of , or will change the existingPsoriasis Treatment Landscape.

Clinical Data Superior to Marketed Therapies

This application includes four key3Phase clinical research data, these studies are allICONICPart of the clinical development program(IncludingICONIC-LEAD、ICONIC-TOTALandICONIC-ADVANCE 1AndICONIC-ADVANCE 2）。

JNJ-2113 Successfully Achieved All Primary and Co-Primary Endpoints in the Above Phase 3 Study, in Adults and Pediatric Patients Aged 12 Years and Older with Moderate to Severe Plaque Psoriasis.Showed significant skin symptom clearance and good safety.

ICONIC-LEADResearch shows that at 16 weeks of JNJ-2113 treatment, 65% of patients achieved an IGA score of 0/1 (clear or almost clear skin symptoms), and 50% of patients achieved PASI 90, while in the placebo group, the values for these two indicators were only 8% and 4%, respectively.

The study has two primary endpoints, which are:

1）16Overall Investigator Assessment at Week IGA 0/1And the score change>=2The proportion of subjects;

2）16Weektime Achievement of Area and Severity IndexPASI 90The proportion of subjects.

To the24Week, the patient's remission rate further increased,74%of patients achievedIGAScore:0/1，46%AchieveIGA 0Points;65%of patients achievedPASI 90，40%AchievePASI 100。

InICONIC-ADVANCE 1And2In the study, JNJ-2113 demonstrated superior efficacy compared to the marketed oral psoriasis therapy deucravacitinib. Deucravacitinib is reported to be the world's first oral selectiveTYK2Inhibitor, byBMSR&D.

In terms of safety,JNJ-2113Overall Tolerability Was Good.Integration of all research data shows that treatmentGroup (49.1%) and the placebo group (51.9%) have similar incidence rates of adverse events, and no new safety signals have been identified so far.

Johnson & Johnson's "Patent Cliff" Dilemma

From the perspective of its own pipeline, Johnson & Johnson is undoubtedly the "leader" in the field of psoriasis treatment. The company boasts several blockbuster products in the autoimmune area, such as psoriasis, including ustekinumab, infliximab, golimumab, and guselkumab, forming a product matrix that covers a wide range of treatment needs. Among them, ustekinumab is an undisputed blockbuster with sales exceeding billions of dollars.2024Global sales reached in year103.6Billion US dollars.

However, the patent for this drug in the United States has already2023Year9The month is up, and Amgen immediately launched a biosimilar. Johnson & Johnson used legal means to obstruct the listing process of the biosimilar, but this was merely a delaying tactic. Currently, Samsung Bioepis, Sandoz, Teva,Biocon、Celltrion, Bio-Thera, Fresenius and other companies have successively obtained relevant approvals, leading to increasing market competition pressure.

The current Johnson & Johnson,Core product ustekinumab is facing a "patent cliff," with sales showing a downward trend.; while the growth of another drug, Guselkumab, is also slowing down. Johnson & Johnson urgently needs a new drug to take over, in order to support its product portfolio in the field of autoimmune diseases. OralIL-23Receptor AntagonistJNJ-2113This advancement is an important step for Johnson & Johnson to consolidate and expand its leading position in the field of psoriasis treatment.

From the perspective of market demand, the field of psoriasis treatment has enormous potential.Due to the slow progression of the disease, most patients require long-term or even lifelong treatment.A massive patient base and long-term medication needs have given rise to a market worth tens of billions of dollars.As of2023Year6Month's12Within months, the global psoriasis drug market size is approximately340billion dollars, accounting for the overall market of immune diseases30%Left and right.

Consolidating the billion-dollar market for psoriasis has become one of Johnson & Johnson's top priorities in overcoming its challenges.

Johnson & Johnson's Breakthrough Path —— Oral Peptides

As efficacy generally improves, the convenience of medication and patient compliance are becoming key factors influencing treatment choices.The development of convenient, safe, and efficient oral medications has become the "pinnacle" that major pharmaceutical companies are vying for.Particularly in the long-term management of chronic diseases, oral dosage forms demonstrate significant clinical value and market potential.

Among them, polypeptide drugs not only inherit the advantages of high affinity and high specificity from antibody-based macromolecule drugs but also possess the benefits of being synthesizable through chemical methods and having relatively lower production costs, demonstrating promising development prospects and commercialization potential. If technical bottlenecks can be overcome,Achieving an oral administration method similar to small-molecule drugs is expected to significantly improve the convenience of medication and patient compliance while maintaining their excellent efficacy., thereby significantly enhancing its clinical value and market competitiveness.

Has received much attention in recent yearsGLP-1Receptor Agonist——Semaglutide (Semaglutide) is a typical case. The drug originally required subcutaneous injection, but Novo Nordisk utilized“SNACAbsorption Enhancer”This innovative technology has successfully led to the development of an oral dosage form.Rybelsus, achievingGLP-1A historic breakthrough in the administration of this class of drugs via the oral route,MakeRybelsusTo become the world's first truly oral polypeptide drug.

AndJNJ-2113The listing or will replicate this path, relying onProtagonistExclusive polypeptide technology platform,Successfully broke through the development bottlenecks of orally administered peptide drugs, such as low bioavailability, poor permeability and stability, and susceptibility to gastrointestinal degradation.。JNJ-2113Capable of binding with high affinity at single-digit picomolar levelsIL-23R, and in humanTIn cells,IL-23The signaling pathway exhibits potent and selective inhibitory effects, demonstrating significant therapeutic potential.

To ProveOral Efficacy of JNJ-2113Johnson & Johnson has chosen to "head-to-head" itself. The company launched aIIIPeriodICONIC-ASCENDfResearch, Aimed at Proving Oral MedicationJNJ-2113Superior to Injected BiologicsUstekinumab。

In addition, AbbVie is also actively expanding into the psoriasis oral medication field, not long agoAcquired a biotechnology company focused on developing oral peptide therapiesNimble Therapeutics, and acquire its core assets, including the main project——Oral PeptidesIL-23Receptor inhibitors, as well as a pipeline of innovative oral peptide drug candidates covering various autoimmune diseases.

It is worth noting that,IL-23The target is the same as AbbVie's blockbuster injectable Risankizumab, indicatingNimbleThe R&D direction is highly consistent with its existing product line, featuring significant synergy, and is expected to achieve a smooth transition from injection to oral treatment pathways.

Conclusion

However, the development and production of oral peptide drugs still face many challenges.

Peptide drugs typically have complex structures and poor stability, requiring extremely high precision in synthesis and production. They are highly prone to degradation during preparation and storage. Compared with traditional small-molecule drugs, the production cost of peptide drugs is higher, especially in ensuring their biological activity and stability, which often requires more resources and technical support.

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