October 30, 2020
1 min read
Papp KA, et al. A phase 2b, randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy, safety and tolerability of sonelokinab (M1095), an IL-17A/F nanobody, in patients with moderate-to-severe chronic plaque psoriasis: Results from 24 weeks. Presented at: European Academy of Dermatology and Venereology congress; Oct 29-31, 2020 (virtual meeting).
Papp reports he has financial relationships with AbbVie, Active Biotech, Akesis, Allergan, Amgen, Anacor, Astellas, AstraZeneca, Avillion, Basilea, Bausch Health, Baxter, Bayer, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite, Cato, Cepheid, Celgene, Centacor, Cipher, Coherus, Dermira, Dow Pharma, Eli Lilly, Endocyte, Ferring Pharma, Galderma, Genentech, Gilead, GlaxoSmithKline, Incyte, Janssen, Kyowa Hakko Kirin, Kythera, Leo Pharma, Medimmune, Meiji Seika Pharma, Merck Sharp & Dohme, Merck Serono, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals, Rigel, Roche, Sanofi-Aventis, Sosei, Sun Pharma, Takeda, UBC and Vertx.
Sonelokinab showed efficacy through 24 weeks of treatment in moderate to severe plaque psoriasis, according to phase 2b study results presented at the European Academy of Dermatology and Venereology virtual congress.
Sonelokinab is a trivalent camelid nanobody comprised of an IL-17F and an IL-17AF inhibitor, both bound with albumin, Kim A. Papp, MD, said.
“Binding with albumin prolongs the half-life to 12 days,” he said.
Kim A. Papp
The multicenter, double-blind, double-dummy, placebo-controlled phase 2b study included six patient arms. The sonelokinab arms included 30 mg, 60 mg or 120 mg doses every 2 weeks from week 0 through 8, as well as an enhanced cohort that received 120 mg every 2 weeks through week 10. The additional cohorts included a placebo group and a comparator group that received secukinumab 300 mg at weeks 0, 1, 2, 3, 4 and 8.
While all treatment groups saw improvement, the 120 mg cohort showed significant improvement with an Investigator’s Global Assessment score of 0/1 in 88.2% and a Psoriasis Area and Severity Index 90 score in 76.5% at week 12. PASI100 was achieved in 33.3%.
“Patients in the 120 mg cohorts generally maintained high levels of response around week 12 and maintained those high levels of response through week 24,” Papp said.
IGA response rates for the higher doses ranged from 80.4% to 94.2% at week 24, with PASI90 rates between 79.2% and 90.4% and PASI100 rates of 40.4% to 56.9%.
Adverse events were recorded in 50% of patients, with most being mild to moderate. These included nasopharyngitis and pruritus. Five patients had serious adverse events not related to the study drug, and three discontinued treatment.
“These results support the emerging role of IL-17AF mechanism of action and are the first important steps in exploring the nanobody platform for the treatment of inflammatory conditions,” Papp said.