Protagonist Therapeutics Submits NDA for Icotrokinra, a Potential Game-Changer for Plaque Psoriasis Treatment.

Protagonist Therapeutics has submitted a New Drug Application to the FDA for icotrokinra, an oral peptide therapy for plaque psoriasis. The therapy showed superior efficacy over deucravacitinib and comparable safety to placebo in four Phase 3 trials. Icotrokinra offers the convenience of a once-daily pill and has potential applications in other indications such as psoriatic arthritis and Crohn's disease.

Protagonist Therapeutics has submitted a New Drug Application (NDA) to the FDA for icotrokinra, an oral peptide therapy for plaque psoriasis. The NDA, submitted by Johnson & Johnson (JNJ) on behalf of Protagonist Therapeutics, seeks approval for icotrokinra in adults and pediatric patients aged 12 years and older with moderate-to-severe plaque psoriasis (PsO) [1].

The application is based on data from four Phase 3 studies, ICONIC-LEADa, ICONIC-TOTALb, and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2, which demonstrated significant skin clearance and a favorable safety profile with once-daily oral dosing [2]. Icotrokinra, an IL-23 inhibitor, showed superiority over deucravacitinib in two of the studies, ICONIC-ADVANCE 1 & 2, achieving co-primary endpoints of Investigator’s Global Assessment (IGA) 0/1 and Psoriasis Area and Severity Index (PASI) 90 [3].

Icotrokinra's potential extends beyond psoriasis, with ongoing development in other IL-23-driven diseases such as psoriatic arthritis and inflammatory bowel disease (IBD). Earlier this year, the Phase IIb ANTHEM-UC study showed positive results for icotrokinra in adults with moderately to severely active ulcerative colitis [3]. J&J is also conducting the Phase 3 ICONIC-ASCEND study to compare icotrokinra with its blockbuster immunology drug, Stelara (ustekinumab), aiming to offer a more convenient oral alternative [1].

J&J's shares have rallied 13.7% so far this year, outperforming the industry decline of 2.1% [1]. The company's Zacks Rank is currently #2 (Buy), indicating a positive outlook [1].

References:
[1] https://www.nasdaq.com/articles/jnj-seeks-fda-approval-oral-psoriasis-drug-icotrokinra
[2] https://www.nasdaq.com/articles/johnson-johnson-submits-nda-icotrokinra-plaque-psoriasis
[3] https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis