EXTENDING A PIPELINE INTO THE FUTURE OF SKIN HEALTH
About AhR
The aryl hydrocarbon receptor (AhR) is a ligand-dependent transcriptional factor that plays a role in the expression of a wide range of genes involved in maintaining a stable environment. In particular, AhR has roles in maintaining homeostasis in barrier tissues such as the skin, lung, and gut.1
THE AhR SIGNALING PATHWAY
From extracellular ligand to gene expression
- Signaling begins when a ligand binds to AhR in the cell cytoplasm, forming an AhR-ligand complex1
- The AhR-ligand complex translocates to the nucleus and heterodimerizes with the AhR nuclear translocator (ARNT) to form a high affinity DNA-binding transcriptional regulatory complex2,3
- The activated AhR-ligand/ARNT complex then interacts with DNA to promote modulation of various AhR-responsive genes1–3
EXAMPLES OF BARRIER TISSUES
SKIN4
- Regulates activation of T cells and antigen-presenting cells
- Normalizes the expression of pivotal barrier proteins and terminal differentiation of keratinocytes
- Protects against oxidative stress
LUNGS4
- Regulates inflammatory and immune responses
GUT4
- Important for the development of intestinal epithelium
- Maintenance of intestinal epithelial integrity and regulation of innate gut immune cells.
Product Candidate
Potential Indication
Stage of Development
Preclinical
Phase 1
Phase 2
Phase 3
FDA Review
Commercial
DMVT-506
Next-generation aryl hydrocarbon receptor (AhR) agonist under development for multiple routes of administration
Immunological and Inflammatory Diseases
Progress value is 10%
10%DMVT-506
Indication: Immunological and Inflammatory Diseases
An early-stage drug candidate currently in development as a potential treatment for immunological and inflammatory diseases.
Product Candidate
Indication
Stage of Development
Preclinical
Phase 1
Phase 2
Phase 3
FDA Review
Commercial
VTAMA® (tapinarof) cream, 1% (DMVT-505)
A topical aryl hydrocarbon receptor (AhR) agonist
Plaque Psoriasis in Adults
Progress value is 100%
100%VTAMA® (tapinarof) cream, 1% (FDA approved)
Indication: Plaque Psoriasis in Adults
A post-marketing phase 4 study of VTAMA cream in adults with plaque psoriasis in the in intertriginous areas (i.e., skin folds).
Read Press ReleaseVisit ClinicalTrials.gov
A post-marketing phase 4 study of VTAMA cream in adults with plaque psoriasis in the head and neck regions.
Read Press ReleaseVisit ClinicalTrials.gov
Tapinarof (DMVT-505)
A topical aryl hydrocarbon receptor (AhR) agonist
Atopic Dermatitis
Progress value is 64%
64%Tapinarof cream, 1%
Indication: Atopic Dermatitis
A maximal usage study of tapinarof cream in children ages 2 to 17 years with atopic dermatitis.
Read Press ReleaseVisit ClinicalTrials.gov
Topline results from the Phase 3 ADORING 1 and ADORING 2 program.
Read Press ReleaseVisit ClinicalTrials.gov
DMVT-506
Next-generation aryl hydrocarbon receptor (AhR) agonist under development for multiple routes of administration
Immunological and Inflammatory Diseases
Progress value is 10%
10%DMVT-506
Indication: Immunological and Inflammatory Diseases
An early-stage drug candidate currently in development as a potential treatment for immunological and inflammatory diseases.
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References:
1. Esser C, Rannug A. Pharmacol Rev. 2015;259-275.
2. Furue M, et al. J Dermatol Sci. 2015;80:83-88.
3. Bissonnette R, et al. J Am Acad Dermatol. 2021;84:1059-1067.
4. Esser C, et al. Pharmacol Rev. 2015;67:259-279.
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Important Safety Information
Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for:
- the topical treatment of plaque psoriasis in adults.
- the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis); pain or swelling in the nose and throat (nasopharyngitis); skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis); headache; itching (pruritus); and flu (influenza).
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection; red raised bumps around the hair pores (folliculitis); lower respiratory tract infection; headache; asthma; vomiting; ear infection; pain in extremity; and stomach-area (abdominal) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.