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S-1
VITAE PHARMACEUTICALS, INC filed this Form S-1 on 08/12/2014
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Inhibition of IL-6 Secretion by THP-1 Macrophages

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Figure 23: VTP-38543 significantly decreased expression of IL-6 in activated THP-1 macrophages.

        In order to further progress VTP-38543 as a clinical candidate, we identified two suitable topical formulations with appropriate drug stability, release, permeation and aesthetic characteristics. VTP-38543 was formulated in these two topical formulations and then applied to the skin of hairless mice in order to determine if an LXR dependent marker of barrier function could be induced with these formulations. As shown in Figure 24 below, both topical formulations of VTP-38543 produced strong, dose-dependent induction of the marker ABCG1 in mouse skin.

ABCG1 Gene Induction in
Mouse Skin (formulation 1)
  ABCG1 Gene Induction in
Mouse Skin (formulation 2)


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Figure 24: VTP-38543 induced ABCG1 in mouse skin when applied topically.

    Development Plans

        VTP-38543 is in preclinical development for the LXR dermatology program. We anticipate filing an IND for VTP-38543 in the second half of 2015. We expect that the first Phase 1 clinical trial will be a single topical dose study in healthy volunteers. The endpoints for the clinical trial will be safety and tolerability, pharmacokinetics if there are detectable drug levels in plasma, and biomarkers of increased lipid synthesis and transport in skin biopsies. The second clinical trial is expected to be a two week, topical multiple dose Phase 1 trial. It will be performed in young adults with atopic dermatitis. In addition to safety, tolerability, and pharmacokinetics, improvement in the clinical signs and symptoms of the atopic dermatitis will be assessed.

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