https://www.ncbi.nlm.nih.gov/pubmed/30926369?dopt=Abstract
https://www.jaad.org/article/S0190-9622(19)30500-6/pdf
Related Articles
A randomized, double-blind, placebo-controlled phase 1 study of multiple ascending doses of subcutaneous M1095, an anti-interleukin-17A/F Nanobody®, in moderate-to-severe psoriasis.
J Am Acad Dermatol. 2019 Mar 26;:
Authors: Svecova D, Lubell MW, Casset-Semanaz F, Mackenzie H, Grenningloh R, Krueger JG
Abstract
BACKGROUND: Interleukin 17 (IL-17) is involved in the pathogenesis of psoriasis, a chronic, debilitating disease.
OBJECTIVES: To evaluate safety/tolerability, immunogenicity, pharmacokinetics/pharmacodynamics and efficacy of M1095 (ALX-0761), an anti-IL-17A/F Nanobody®, in moderate-to-severe plaque psoriasis.
METHODS: This multicenter, double-blind, placebo-controlled dose-escalation phase 1 study randomized 44 patients 4:1 to subcutaneous M1095 (30, 60, 120, or 240 mg) or placebo bi-weekly for 6 weeks, in 4 ascending dose cohorts.
RESULTS: The most frequent treatment-emergent adverse events (AEs) with M1095 were pruritus (n=4) and headache (n=3); two patients withdrew due to AEs (injection site reaction, and elevated liver enzymes). Terminal half-life of M1095 was 11-12 days. AUC/Cmax was dose-proportional. Five of 10 M1095-treated patients (positive for anti-drug antibodies) showed treatment-emergent anti-drug antibody responses with no effect on M1095 exposure. Marked decreases in psoriasis inflammatory markers were observed with M1095. By Day 85, 100% and 56% of patients receiving M1095 240 mg achieved psoriasis area and severity index 90 and 100, respectively. Improvements in static physician’s global assessment, and affected body surface area were also seen.
LIMITATIONS: Interpretation of efficacy data is limited by the small sample size.
CONCLUSION: Multiple subcutaneous doses of M1095 showed a favorable safety profile with dose-dependent improvements in psoriasis.
PMID: 30926369 [PubMed – as supplied by publisher]
A randomized, double-blind, placebo-controlled phase 1 study of multiple ascending doses of subcutaneous M1095, an anti-interleukin-17A/F Nanobody®, in moderate-to-severe psoriasis.
PubMed:30926369
Last Update Posted: 03/31/19 06:04AM