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BI 730357, a RORγt inhibitor, for moderate-to-severe plaque psoriasis
By Ella Dixon
|
Dysregulation of IL-23/Th17 signaling is critical to psoriasis pathogenesis. RORγt, a transcription factor involved in IL-23-induced Th17 differentiation and IL-17A and IL-17F production, increases susceptibility to autoimmune diseases such as psoriasis. A phase II, double-blinded, placebo-controlled, randomized clinical trial (NCT03635099) investigated BI 730357, an oral RORγt inhibitor, in patients with moderate-to-severe plaque psoriasis. In part 1 of the study, 178 patients were randomized 2:2:2:2:1 to BI 730357 at 25, 50, 100, or 200 mg QD, or placebo under fasted conditions, respectively. In part 2, a different group of 133 patients were randomized 4:4:1 to BI 730357 400 mg QD, 200 mg BID, or placebo under fed conditions, respectively. Results were published by Gooderham et al. in the Journal of Investigative Dermatology. |
| Key learnings |
| The highest efficacy was seen with BI 730357 at 200 mg QD, with 30% of patients achieving the primary endpoint of PASI 75 at 12 weeks and 35% at 24 weeks, compared with 0% in the placebo group. No significant increases in response were seen with >200 mg QD doses. |
| BI 730357 was generally well tolerated, with drug-related AEs occurring in ≤15.8% of patients. In part 1 of the study, three patients discontinued treatment due to AEs. |
| The long-term extension trial was discontinued due to limited efficacy and concerns from a nonhuman carcinogenicity study. |
| While RORγt inhibition showed some promise in reducing psoriatic lesions, it did not achieve efficacy levels comparable with biologic therapies targeting IL-17 or IL-23 and therefore has limited potential in the psoriasis treatment landscape. |
Abbreviations: AE, adverse event; BID, twice daily; IL, interleukin; PASI, Psoriasis Area and Severity Index; QD, once daily; RORγt, retinoic acid-related orphan receptor.
- Gooderham MJ, Mrowietz U, Kadus W, et al. Phase II randomized trial of BI 730357, a novel oral RORγt inhibitor, for moderate-to-severe plaque psoriasis. J Invest Dermatol. 2025. Online ahead of print. DOI: 1016/j.jid.2024.12.025
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