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Systemic Lupus Erythematosus (SLE): Update Bulletin #3 [May 2018]

Product Code:
Publication Date:
May 2018

This edition presents key opinion leader (KOL) views on recent developments in the treatment of SLE. Topics covered include: KOL views on Neovacs’ interferon alpha-kinoid (IFN alpha-kinoid) vaccine, which is currently in Phase IIb development; initial data is expected in mid-2018 following a positive review of the trial protocol by the Independent Data and Safety Monitoring Board (IDSMB). KOL views on anti-interleukin-6 therapies as an approach to the management of SLE are also explored following Ablynx’s announcement in March 2018, that the Phase II dose-ranging STEADY trial, evaluating the Nanobody vobarilizumab, did not meet the study’s primary endpoint; and top line results from ImmuPharma’s Phase III study with immunotherapy Lupuzor (forigerimod) are also discussed, following the company’s announcement that the trial failed to reach clinical significance.

Business Questions:

  • In February 2018, the Independent Data and Safety Monitoring Board (IDSMB) issued a positive data review with respect to Neovacs’ Phase IIb trial with the company’s interferon alpha-kinoid (IFN alpha-kinoid) vaccine, but how positively do opinion leaders view the novel immunomodulatory action of this therapy?
  • Neovacs is preparing to publish initial results from the Phase IIb study by mid-2018, but what expectations do KOLs have with regard to this therapy and how robust is the clinical trial design?
  • Given the central role of interferon in the immune response, what concerns, if any, do KOLs have with regard to IFN alpha-kinoid’s safety profile?
  • If approved, where in the current treatment paradigm will IFN alpha-kinoid be used, and which patients will be the most appropriate candidates for therapy?
  • In March 2018 Ablynx announced that its investigational anti-interleukin-6 (anti-IL-6) therapy vobarilizumab, had failed to meet the primary endpoint in the Phase II STEADY trial, but how confident are opinion leaders regarding the utility of this mechanism of action in the treatment of SLE?
  • What do opinion leaders consider to be the future potential of vobarilizumab, given that the product is a Nanobody, designed to have therapeutic and commercial benefits over conventional monoclonal antibodies?
  • What impact, if any, will the failure of the Phase II STEADY trial have on the future development of anti-IL-6 therapies for the treatment of SLE?
  • ImmuPharma’s immunomodulatory therapy Lupuzor (forigerimod) failed to reach statistical significance in a pivotal Phase III clinical study according to an April 2018 press release, but how do opinion leaders view this novel therapy?
  • How robust was ImmuPharma’s Phase III clinical study protocol? Are there any features of the study design that may explain Lupuzor’s failure to reach statistical significance?
  • Are opinion leaders in agreement with ImmuPharma’s assertion that the top-line results support further investigation into the development and commercialisation of Lupuzor for this indication?
  • In February 2018, Abbvie presented positive results from the UltiMMa-1 and UltiMMa-2 Phase III clinical trials, illustrating the superiority of interleukin-23 (IL-23) inhibitor risankizumab compared with marketed biological therapy Stelara (ustekinumab; Janssen Biotech), but how do key opinion leaders perceive the data from these pivotal trials?
  • If approved, how can risankizumab differentiate itself from an increasingly crowded market populated with efficacious biological therapies?
  • How and where in the treatment paradigm for moderate-to-severe psoriasis will risankizumab be used?
  • How do key opinion leaders perceive Sun Pharmaceuticals’ second-in-class IL-23 inhibitor Ilumya (tildrakizumab)?
  • Ilumya met the primary endpoints in the reSURFACE Phase III development program, but are the results sufficient to establish this product as a viable competitor to marketed biological therapies for the treatment of moderate-to-severe psoriasis?
  • Bristol Myers Squibb’s BMS-986165 represents a novel approach in the treatment of moderate-to-severe psoriasis, targeting tyrosine kinase 2 (Tyk2), but how viable do opinion leaders consider this mechanism of action, and what concerns if any do they have about inhibiting this pathway?
  • If approved, where in the treatment paradigm will BMS-986165 sit, and what products will it compete with?
  • How do opinion leaders view MetrioPharm’s novel macrophage-targeting therapy MP1032 in the treatment of moderate-to-severe psoriasis?
  • As MP1032 moves into Phase IIb development, how optimistic are opinion leaders with regard to the potential of this product?


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