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PTGX Up as J&J-Partnered Drug Meets Goal in Ulcerative Colitis Study
ZACKSยท2025-03-11 17:20

Core Insights - Protagonist Therapeutics, Inc. (PTGX) announced positive top-line data from the phase IIb ANTHEM-UC study for icotrokinra, a targeted oral peptide for treating moderately to severely active ulcerative colitis (UC) [1][2] - The study met its primary endpoint of clinical response across all icotrokinra dose groups, with significant improvements in secondary endpoints [2][4] - Following the announcement, PTGX shares surged by 45.9% on March 10, and the stock has increased by 87.4% over the past year, contrasting with an 8.5% decline in the industry [2][3] Study Details - The ANTHEM-UC study was a randomized, placebo-controlled trial evaluating three once-daily oral dosages of icotrokinra in patients with inadequate response or intolerance to conventional therapy [4] - The highest dose of icotrokinra achieved a response rate of 63.5% compared to 11.1% for placebo, with 30.2% of patients in the highest dose group showing clinical remission at week 12 [5] Partnership and Development - Icotrokinra was jointly discovered by Protagonist and Johnson & Johnson (JNJ), with JNJ holding exclusive worldwide rights for further development [6][7] - Icotrokinra is also being investigated in the pivotal phase III ICONIC clinical program for moderate-to-severe plaque psoriasis and active psoriatic arthritis [7] Additional Studies - Recent data from the phase III ICONIC-LEAD study indicated that nearly half of patients with moderate-to-severe psoriasis treated with icotrokinra achieved completely clear skin at week 24 [8] - In the phase III ICONIC-ADVANCE 1&2 studies, icotrokinra demonstrated superiority over Bristol Myers' Sotyktu, leading to plans for a head-to-head study against JNJ's Stelara [9][10]