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Merck announces positive results from its phase 2b trial evaluating sonelokinab, an investigational anti-IL-17 A/F nanobody, in adult patients with moderate-to-severe chronic plaque psoriasis.
Merck has announced positive results from its phase 2b study investigating sonelokinab (M1095) in patients with moderate-to-severe chronic plaque psoriasis.
Sonelokinab is an investigational anti-interleukin-17 (IL-17) A/F nanobody with a bi-specific half-life-extended nanobody believed to neutralize IL-17A and IL-17F. Currently, there are no IL-17 A/F nanobodies approved by regulatory authorities, according to the press release.
"This Phase II study was conducted by Avillion as part of an innovative co-development model and we thank them for their partnership and successful completion of this trial with high quality data," says Luciano Rossetti, head of Global Research & Development for the biopharma business of Merck. "Given the encouraging Phase II results we will explore partnership options to rapidly deliver this promising new therapy to patients living with psoriasis."
First announced in 2017, the study is a phase 2b, randomized, placebo-controlled, multicenter, double-blind clinical trial evaluating the safety, tolerability and efficacy of sonelokinab in 313 adult patients with moderate-to-severe chronic plaque psoriasis over the course of six months. In the study, patients were randomized to either receive one of four dose regimens of sonelokinab, or placebo, or secukinumab (reference arm).
Results of the study demonstrated sonelokinab achieved its primary endpoint of Investigator Global Assessment (IGA) response of at least a 2-point reduction from baseline. Additionally, sonelokinab met its secondary endpoint of achieving Psoriasis and Severity Index (PASI) with high statistical significance (p<0.001).
"The Phase II study results for sonelokinab provide valuable insights. The onset of action and potential durable response of sonelokinab in psoriasis patients merits further characterization in a comprehensive Phase III program," says Kim Papp, M.D., Ph.D., FRCPC, primary investigator of the study.
Merck plans on presenting the study’s full results at an upcoming international conference and submitting data for publication in a peer-reviewed medical journal, according to the press release.
1. Merck. (2020, September 10). Merck Announces Positive Phase II Results for Investigational Sonelokinab (M1095) in Patients with Moderate to Severe Chronic Plaque-Type Psoriasis. Retrieved September 17, 2020, from https://www.prnewswire.com/in/news-releases/merck-announces-positive-phase-ii-results-for-investigational-sonelokinab-m1095-in-patients-with-moderate-to-severe-chronic-plaque-type-psoriasis-830813925.html