A significant shift within the psoriasis landscape and the larger immunology market is taking shape. In the coming months and years, industry attention will turn towards the pipeline assets of Janssen’s JNJ-2113 (also known as JNJ-77242113, FKA PN-235) and Lilly’s DC-806, currently in Phase III and Phase II clinical development, respectively.

The interest and significance of these assets is centered around their respective mechanisms of action through disruption of interleukin (IL) signalling, either through cytokine interference concerning DC-806, or the inhibition of IL receptor (ILR), as with JNJ-2113. The novelty of these pipeline agents is due to both being small molecules, and thereby able to be administered orally.

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With the advent of biologics, monoclonal antibodies (mAbs) have provided effective therapies — as seen with AbbVie’s Skyrizi and Humira, Takeda’s Entyvio and Novartis’s Cosentyx — and are a drug modality of great importance in immunological diseases. Targeting cytokine signalling typically is done using mAbs. However, unlike small molecules, developing mAbs to be administered orally is difficult due to their physical instability, low permeability across the gastrointestinal membrane and vulnerability to enzymatic activity. Therefore, mAbs are usually developed to be administered at low doses parenterally, either intravenously or subcutaneously. Earlier programmes developing small molecules targeting ILs have shown little progress or traction due to a lack of therapeutic efficacy or increased toxicity.

The potential market impact of JNJ-2113 or DC-806, as oral treatments capable of targeting IL signalling, could be immense. A small molecule capable of effectively altering IL signalling is a significant point of distinction from all currently approved therapies. Of note and interest is JNJ-2113, due to its recent reporting of its positive Phase IIb, FRONTIER 1 (NCT05223868) data. Findings showed JNJ-2113 to be highly effective in treating plaque psoriasis with a good safety profile. The positive results have provided Janssen with the confidence to enable ICONIC-ADVANCE 1 (NCT06143878), a Phase III clinical trial evaluating JNJ-2113 against an active comparator, Bristol Myers Squibb’s selective tyrosine kinase 2 (TYK2) inhibitor Sotyktu (deucravacitinib). If proven to be more effective than Sotyktu, it will put Janssen’s asset at a very strong strategic advantage in the psoriasis and immunological landscape. This will allow Janssen to price JNJ-2113 at a premium relative to Sotyktu and other selective JAKis coming down the pipeline. This trial also signals the intent of Janssen to establish JNJ-2113 as the premier oral option in treating psoriasis and other potential immunological indications.

It should also be noted that Janssen, Lilly or other companies working in the space of oral therapeutics being developed against traditional biological targets can potentially establish their assets with therapeutic efficacy comparable with approved biologics through pursuing non-inferiority. By aiming for the lower statistical bar of non-inferiority, as opposed to superior effectiveness of statistical significance, the argument of a treatment that is as good as current, established therapies can be made. The fact that these agents are expected to be set at a lower price point than the typically more expensive biologics will only strengthen their standing in the market.

Update: The fourth paragraph of this article was updated on 7 June to reflect the correct mechanism of action of Sotyktu.

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