On June 26, Novartis published data from their latest Phase II study in psoriasis patients.
Results show that Cosentyx (secukinumab) modulates gene expression, leading to substantial improvement of inflammation, as early as 12 weeks post-treatment.
In addition to this, Cosentyx also induces rapid and sustained suppression of additional cytokines such as IL-23 and IL-17F in addition to the known IL-17A suppression. With this dual inhibition mechanism, GlobalData expects that Cosentyx will change the landscape of the psoriasis market, which could give Novartis a competitive advantage over other marketed therapies, posing a threat to the IL-23 class of drugs.
In the randomised, double-blinded, placebo-controlled Phase II clinical study, four assessments were performed to measure the effectiveness of Cosentyx in psoriasis patients.
This includes clinical assessments using Psoriasis Area and Severity Index (PASI)/Investigator’s Global Assessment (IGA) and Dermatology Life Quality Index (DLQI), skin biopsies, ex vivo T cell activation, and peripheral blood mononuclear cells as biomarkers.
Patients were segmented into two arms; in the Cosentyx-treated arm, patients were given 300mg of Cosentyx for four weeks in the first month and then monthly doses for up to 12 weeks. Additionally, 12 patients were treated in the placebo arm.
After 12 weeks of treatment, Cosentyx reversed plaque histopathology in 56.5% of treated patients compared with 0% of placebo-controlled patients. Cosentyx did not affect the ex vivo T cell activation, which is consistent and favourable for a long-term safety profile.
Interestingly, transcriptome analysis was also performed, which showed that Cosentyx can modulate gene expression in psoriasis patients.
Results show that Cosentyx induces a rapid and sustained suppression of additional cytokines including IL-23 and IL-17F. Suppression of the IL-23/IL-17 axis by Cosentyx was evident at week 1 and continued through week 12, including reductions in the upstream cytokine IL-23, drug target IL-17A, and downstream inflammatory targets including beta-defensin 2. Furthermore, suppression of the IL-23/IL-17 axis by Cosentyx at week 4 was associated with clinical and histological responses at week 12.
With this data in mind, Novartis has demonstrated strong results in its Phase II study, which could give the company an advantage in a fiercely competitive psoriasis market.
As Cosentyx acts as a dual inhibitor, suppressing IL-17 and IL-23 expression in psoriasis-treated patients, the drug could dominate other IL-17 inhibitors such as Taltz (ixekizumab) and Siliq (brodalumab) as well as IL-23 inhibitors such as Tremfya (guselkumab) and Ilumya (tildrakizumab), persuading physicians and dermatologists to steer away from IL-23 monoclonal antibody treatment.
This data might also come at a bad time for AbbVie’s enhanced efforts to market its newly approved IL-23 inhibitor, Skyrizi (risankizumab).
Overall, Novartis’ new data could turn physicians’ and dermatologists’ attention in the direction of Cosentyx and give it the boost it needs to push for top-selling status.