Global litifilimab phase 2/3 study has seen the first patient dosed with Biogen’s therapy. The company announced that the participants of the litifilimab (BIIB059) study are those with CLE (cutaneous lupus erythematosus).
Prior to this, the phase 2 Lilac study was conducted for litifilimab, which was published in July. Disclosed results were that litifilimab treatment was superior to placebo in skin disease activity measured over a period of 16 weeks. The phase 2/3 study will test efficiency over a lengthier period than that.
CLE is a long-term autoimmune skin disease, the occurrence of which may be with or without any systemic indications. The most commonly experienced symptoms are itch, pain, rash and photosensitivity. The symptoms related to skin damage that may get worse over time are alopecia, pigmentation, and permanent scarring, all of which can affect the quality of life considerably.
Even though the development of lupus is not specific to any gender, the number of people that have lupus are skewed towards the female gender as nine out of ten people suffering from the condition are women. A majority of these people started to notice the symptoms between the big age range of 15 to 40 years old. The disease is reported to affect various ethno-racial groups that include Asian, American, Hispanic/Latino communities, and American Indian or Alaskan Natives.
A randomized study that goes by the name of AMETHYST is being conducted to assess the effectiveness and safety of the litifilimab therapy. It was a multicentre, placebo-controlled, double-blind, and two-part study that compared litifilimab’s performance across the aforementioned indicators to the placebo. Litifilimab is a humanized IgG1 monoclonal antibody that is aimed at the BDCA2 (blood dendritic cell antigen 2). The main outcome will evaluate the litifilimab’s effect on the skin disease activity.
Bringing litifilimab together with BDCA2 has proved to lower the production of molecules that are pro-inflammatory by pDCs (Plasmacytoid Dendritic Cells, a subset of immune cells). Biogen stated that these mediators seem to play a big part in the pathogenesis of cutaneous and systemic lupus.
The study participants are to be randomized to receive either the placebo or the litifilimab as subcutaneous treatment after every four weeks spanning over a total of 20 weeks. An extra loading dose is to be given at week two. All participants are to receive litifilimab from week 24 to 48 through the extended treatment period that is 28 weeks long.
To conduct the study at a global level, roughly 238 sites will be used and 474 adult participants with CLE will be enrolled across the globe.
Priya Singhal, interim R&D head as well as the global safety and regulatory sciences head at Biogen said, “CLE is more severe and frequent among African American and Hispanic/Latino patients, compared to white patients, which is why for AMETHYST we have set enrolment targets with the objective of appropriate representation for these traditionally underrepresented groups.”
Biogen is working on another lupus therapy for SLE (systemic lupus erythematosus) in partnership with UCB. It is called Dapirolizumab pegol and is in Phase 3 trials.
