Protagonist Therapeutics Inc. (NASDAQ:PTGX), in collaboration with Johnson & Johnson (NYSE:JNJ), released new clinical data from the Phase 3 ICONIC-TOTAL study investigating icotrokinra for scalp and genital psoriasis.
Key findings from the high-impact skin sites cohort:
- At week 16, 57% of patients treated with once daily icotrokinra achieved the study’s primary endpoint with an Investigator’s Global Assessment (IGA) b score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of patients receiving placebo.
- 66% of patients with scalp psoriasis achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) c score of 0/1 compared to 11% receiving placebo at 16 weeks.
- 77% of patients with genital psoriasis achieved a static Physician’s Global Assessment of Genitalia (sPGA-G) d score of 0/1 at 16 weeks, compared to 21% receiving placebo.
- In the smaller subset of patients with hand/foot psoriasis, patients showed a numerically higher rate of skin clearance at Week 16, with 42% achieving a hand and/or foot Physician’s Global Assessment (hf-PGA) e score of 0/1 compared to 26% receiving placebo.
Also Read: Johnson & Johnson, Protagonist Tout Positive Results For Psoriasis Oral Pill Study
In March, the companies announced topline results from ANTHEM-UC Phase 2b study of icotrokinra (JNJ-2113) in adults with moderately to severely active ulcerative colitis (UC).
The study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated.
Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at Week 12.
The company also shared preclinical characterization of PN-881, the first-in-class oral peptide antagonist blocking the three dimeric forms of IL-17 (AA, AF and FF), at the Society for Investigative Dermatology (SID) Annual Meeting.
PN-881 represents Protagonist’s next generation of oral peptides for psoriasis. Key takeaways:
- Exhibited nanomolar to picomolar in vitro potency comparable to UCB SA (OTC:UCBJY) (OTC:UCBJF) Bimzelx (bimekizumab) and superior (70-fold) to Novartis AG’s (NYSE:NVS) Consentyx secukinumab.
- Showed metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.
- Demonstrated PD-based target engagement in a mouse IL-17 challenge model after oral dosing.
- Demonstrated dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.
Price Action: PTGX stock is up 1.87% at $44.74 at the last check on Friday.
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