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Closing in: Novel oral immunotherapies are taking on the biologics
May 06, 2025
Over the past two decades advances in targeted immunotherapy have transformed the treatment of autoimmune and inflammatory diseases by blocking pro-inflammatory signalling pathways.
Therapies targeting inflammatory cytokines, e.g., TNF-α, IL-4, IL-13, IL-17 or IL-23; B-cells and T-cells, and intracellular kinases, e.g., JAK, have become the standard of care for patients with moderate-to-severe disease in many immunology indications, e.g., rheumatoid arthritis, psoriasis, psoriatic arthritis, inflammatory bowel disease or atopic dermatitis, among other conditions.
Biologics, administered intravenously or as a sub-cutaneous injection, dominate the segment of targeted, systemic therapies across major immunology indications and include past and current mega-blockbuster brands, such as Humira, Stelara and Dupixent. Meanwhile, targeted oral therapies have achieved a more modest share of treated patients to date (see Figure 1).
Marketed oral targeted therapies utilise four mechanisms of action (MoAs) that target inflammatory pathways via modulation of phosphodiesterase 4 (PDE4), Janus kinases (JAKs), tyrosine kinase 2 (TYK2) or sphingosine 1-phosphate (S1P). Importantly, each of these MoAs is approved for specific immunology indication(s), not across all of immunology, with JAK inhibitors proving the most versatile.
Despite offering patients the convenience of a pill, current oral targeted immunotherapies have a number of limitations that affect their adoption, for example:
- PDE4 inhibitor Otezla delivers only modest efficacy in psoriasis compared to biologics.
- JAK inhibitors, such as Xeljanz, Olumiant and Rinvoq, are potent drugs with biologic-like efficacy, but they come with a class-wide black box warning about increased risk of serious heart-related events, cancer, blood clots and death; resulting in a label restricting their use to second line.
- TYK2 inhibitor Sotyktu does not carry the back box warning of the JAK inhibitors, despite TYK2 being part of the JAK family, but it does not exhibit the same biologic-like potency.
- S1P inhibitors Zeposia and Velsipity require specific tests prior to treatment initiation in ulcerative colitis, e.g., baseline ECG, ocular and skin examinations, which do not fit with the routine workflows of gastroenterology practices.
Therefore, the ultimate aspiration of reconciling superior, biologic-like efficacy and safety with the convenience of an oral formulation still remains unfulfilled. This creates an opportunity for innovators to develop novel oral therapies with differentiated profiles to address unmet need and expand the use of orals in immunology.
Innovation trends: Novel oral immunotherapies
In the development of novel oral immunotherapies we see innovators pursue three distinct strategies:
- Expanding or improving on existing oral MoAs, e.g., new indications for existing S1P or JAK inhibitors; more potent and/or more selective TYK2 inhibitors
- Building on the tried-and-tested MoAs of biologics, e.g., oral therapies targeting IL-17, IL-23, integrin or TNF
- Exploring novel MoAs for oral therapies, e.g., RIPK1, NLRX1, miR-124, BTK or IRAK4
The mid-/late-stage pipeline for inflammatory bowel disease (IBD) shows these three strategies at work (see Figure 2), and we should expect the oral treatment landscape in IBD to expand significantly over the next few years.
Delivering biologic-like efficacy is the foundational prerequisite for targeted oral immunotherapies to be successful in the segment of patients with moderate-to-severe disease, including both as potential first-line advanced therapy options and in second-line, e.g., in refractory patients or in a maintenance therapy setting.
Recent innovation trends in psoriasis, for example, illustrate that novel oral therapies are narrowing the efficacy gap vs. standard of care biologics, which keep pushing the efficacy frontier, with PASI 100, i.e., full skin clearance, now the benchmark to beat (see Figure 3).
The much anticipated, recent readouts from several phase 3 trials suggest J&J’s oral IL-23 receptor inhibitor icotrokinra has best-in-class potential among novel oral therapies, with efficacy approaching that of biologics:
- ICONIC-LEAD: By week 24, 74% of patients on icotrokinra achieved minimal or no signs of psoriasis (IGA 0/1), and 65% reached PASI 90; 46% of patients treated with icotrokinra achieved completely clear skin (IGA 0), while 40% reached PASI 100.
- ICONIC-ADVANCE: In addition to meeting co-primary endpoints of IGA 0/1 and PASI 90 vs. placebo at week 16, icotrokinra met all key secondary endpoints at weeks 16 and 24 that measured superiority vs. oral TYK2 inhibitor Sotyktu in patients with moderate-to-severe plaque psoriasis.
Following these positive readouts, J&J announced the initiation of ICONIC-ASCEND, a head-to-head phase 3 study of icotrokinra vs. J&J’s own injectable, IL-12/23 inhibitor Stelara in plaque psoriasis. This trial represents a first and is the ultimate test for demonstrating biologic-like efficacy, as it seeks to prove that an oral therapy can outperform an injectable biologic in psoriasis in a direct, head-to-head comparison.
While icotrokinra benefits from the strong safety track record of the IL-23 MoA, it still needs to generate its own long-term safety data to establish itself as a safe and potent oral therapy option.
Beyond autoimmune diseases, oral targeted therapies are also aiming to make inroads in inflammation indications. To date, several oral JAK inhibitors have been approved for the treatment of atopic dermatitis, e.g., Olumiant, Cibinqo and Rinvoq.
Examples of current innovation efforts targeted at inflammation that seek to reshape the biologics-dominated advanced therapy landscape include oral S1P inhibitor Velsipity, which is being investigated in a phase 2 trial in eosinophilic esophagitis; oral IRAK4 degrader SAR444656 in phase 2 for atopic dermatitis; and oral BTK inhibitors for chronic spontaneous urticaria (CSU), including rilzabrutinib in phase 2, and remibrutinib which in its REMIX-1 and REMIX-2 phase 3 trials proved itself as a potential, potent oral CSU therapy with fast onset of action.
Seizing the commercial opportunity for novel oral therapies
Market expansion is critical for oral targeted immunotherapies to fulfil their promise. Today, many patients who are eligible for a targeted therapy do not receive one. For example, treatment rates of targeted therapy eligible patients are around 50% in Crohn’s disease, less than 40% for psoriasis and as low as 10-15% in atopic dermatitis.
Therefore, helped by the greater convenience of their route of administration, oral targeted therapies have a tremendous opportunity to increase market penetration of advanced therapies by expanding use into eligible but targeted therapy naïve patient segments, who currently are sub-optimally treated, e.g., with corticosteroids.
As novel oral therapies embark on seizing the commercial opportunity, they will face a number of challenges:
- Crowding: Multiple, novel oral therapies will launch in next 3-5 years, giving payers choice to extract favourable conditions for reimbursement and granting access, which could erode the size of the commercial opportunity. This will further intensify the already fierce inter- and intra-class competition that is present in many immunology indications today.
- Generics and biosimilars: Generic versions of Otezla are expected to enter the market from 2028 onwards, which will introduce low cost options of a front-line oral therapy in psoriasis and psoriatic arthritis. Furthermore, low(er) cost biosimilars of Stelara will likely be payer-mandated as first-line options in a number of autoimmune indications, thus relegating potential novel oral therapies to second line, especially in Europe. From the end of the decade, biosimilars of other popular MoAs, e.g., IL-17, later IL-23, will further expand available low(er) cost options, and thus increase payer pressure on novel orals.
- Dosing convenience: Future long-acting and ultra-long acting biologics could redefine patient convenience and potentially sway patient preference at the expense of daily oral therapies. For example, already today IL-23 inhibitor Skyrizi only requires quarterly dosing as maintenance therapy in psoriasis; GSK is investigating long-acting IL-5 inhibitor depemokimab in asthma, COPD and chronic rhinosinusitis with nasal polyps, with six-month dosing intervals; while Apogee Therapeutics is developing APG777, an IL-13 inhibitor with an extended half-life, for atopic dermatitis and other inflammation indications, which has the potential for being dosed as infrequently as once a year.
To succeed in the fiercely competitive immunology market, innovators must focus on three strategic priorities:
- Comparative evidence to demonstrate differential value vs. relevant competitors, including via RCTs and RWE.
- Advocacy and early medical engagement to shape guidelines and enable HCPs navigate an increasingly complex treatment landscape.
- Patient support excellence as a differentiator by delivering superior patient outcomes and experiences via personalised engagement, including use of digital health tools.
This is a promising time for immunology patients as many novel oral immunotherapies advance through the pipeline to deliver on the aspiration of combining biologic-like potency, safety and the convenience of a pill.