After being touted as a potential rival to Bristol Myers Squibb’s reigning oral psoriasis med Sotyktu for months, Johnson & Johnson’s IL-23 drug looks like it has a real shot at taking the crown.
The Protagonist Therapeutics-partnered once-daily oral peptide icotrokinra has beaten Sotyktu across a pair of phase 3 studies, dubbed Iconic-Advance 1 and 2, which enrolled patients with moderate to severe plaque psoriasis.
Specifically, icotrokinra showed superior skin clearance at weeks 16 and 24 compared to both Sotyktu and placebo, J&J announced in a Sept. 17 release. When it came to safety, icotrokinra demonstrated a similar rate of adverse events to the placebo cohorts and a numerically lower rate than those on Sotyktu.
These results meant the studies hit both of their co-primary endpoints for efficacy and safety, according to J&J, which is presenting the results at the European Academy of Dermatology and Venereology Congress in Paris this week.
“We’re excited to see the icotrokinra phase 3 Iconic program continue to deliver robust and clinically meaningful head-to-head and long-term results,” Liza O'Dowd, M.D., vice president and immunodermatology and respiratory disease areas lead, Johnson & Johnson Innovative Medicine, said in the release.
“A novel oral therapy that can provide complete skin clearance, a favorable safety profile and the simplicity of a once daily pill may offer an important new option that could increase the use of systemic treatments among patients with moderate-to-severe plaque psoriasis,” O’Dowd added.
The latest results come just days after J&J and Protagonist submitted icotrokinra for approval by European regulators in plaque psoriasis. A submission to the FDA was made back in July. J&J's shares ticked up by a quarter of a percent early Wednesday morning.
Analysts at Jefferies estimated last month that icotrokinra could bring in peak sales of $7.5 billion in the U.S. across various indications, with another $2.1 billion coming from international sales. Meanwhile, analysts at Spherix were suggesting back in April that the drug could be a “game changer” for psoriasis off the back of “robust phase 3 results and clear differentiation from existing oral therapies.”
Momentum started building behind icotrokinra last year when J&J posted results from another phase 3 trial, dubbed Iconic-Lead, which saw 64.7% of treated patients achieve clear or almost clear skin at Week 16 compared to 8.3% of those on placebo.
J&J used this morning’s release to unveil longer-term 52-week data from the Iconic-Lead study, which showed that 86% of adolescents who received icotrokinra and 77% of patients who switched from placebo to icotrokinra at Week 16 saw a 90% or greater reduction in their psoriasis.
“The long-term data from Iconic-lead continue to demonstrate the potential of icotrokinra to address the need for a novel targeted oral psoriasis treatment,” Jennifer Soung, M.D., director of clinical research at Southern California Dermatology and the study’s investigator, said in the same release.
“With a substantial proportion of adults and adolescents achieving clear or almost clear skin while maintaining a favorable safety profile through 52 weeks, icotrokinra could be a compelling new therapeutic option that aligns with both patient and provider goals for an oral treatment once approved,” Soung added.
Icotrokinra, which J&J touts as the first oral peptide designed to selectively block IL-23, was born out of a 2017 collaboration with Protagonist. J&J is currently running a phase 3 psoriasis study pitting the pill against its blockbuster injectable inflammatory med Stelara as well as two late-stage trials assessing icotrokinra for psoriatic arthritis.