Tradipitant

Overview

Tradipitant for Atopic Dermatitis

Tradipitant is being evaluated as a treatment for atopic dermatitis. Vanda recently completed a Phase II study (2102) where tradipitant was shown to improve itch and disease severity in patients with atopic dermatitis. If these results are confirmed in future studies, tradipitant has the potential to become a first line pharmacological option for patients with atopic dermatitis in need of an oral treatment.

Vanda plans to begin a Phase III program for tradipitant as a treatment for atopic dermatitis in the first half of 2018.

Tradipitant is an NK-1 receptor antagonist licensed from Eli Lilly in 2012.

Atopic Dermatitis

Atopic dermatitis is a common inflammatory skin disorder characterized by intense and persistent itch, erythema, excoriation, edema, lichenification, oozing and xerosis.

The estimated U.S. prevalence of atopic dermatitis is 17.8 million1, with approximately 9.8 million who are diagnosed and 4.6 million who are actively treated2.

Treatment for atopic dermatitis often begins with non-pharmacologic measures and progresses to the use of topical corticosteroids, topical calcineurin inhibitors and topical PDE4 inhibitors. Systemic treatments approved by the U.S. Food and Drug Administration include corticosteroids and recently dupilumab, an IL-4 receptor alpha inhibitor, for moderate and severe disease. The American Academy of Dermatology recommends that systemic corticosteroid treatment should be generally avoided because of the potential for short-term and long-term adverse reactions to these agents.

Neurokinin-1 Receptor and Substance P

The neurokinin-1 receptor (NK-1R) is expressed in several tissues of the body, mainly associated with the nervous system. Substance P (SP) and NK-1R are thought to regulate neurogenic inflammation and the pain perception pathway through the central nervous system. Other tissues, including endothelial cells and immune cells, also express NK-1R and could be considered to be targets for NK-1R antagonists2. The activation of NK-1R by the natural ligand SP is thought to be involved in the perception of pain, behavioral stress response, cravings and nausea and vomiting signaling 3,4,5. Abnormal over-expression or over-activation of the NK-1R, either in the central nervous system or peripherally, could result in pathological conditions such as substance dependence, anxiety, nausea/vomiting and pruritus3,4,5,6.

Therefore, an NK-1R antagonist may possess the ability to reduce this over-stimulation of the NK-1R, and as a result address the underlying pathophysiology of the symptoms in these conditions. NK-1R antagonists are currently approved for postoperative and chemotherapy induced nausea.

Learn More about Tradipitant for Atopic Dermatitis

September 2017 press release announcing Phase II study (2102) results. Vanda's Tradipitant Improves Itch and Disease Severity in Patients with Atopic Dermatitis [View Press Release / View Presentation]

Tradipitant Improves Worst Itch and Disease Severity in Patients with Chronic Pruritus Related to Atopic Dermatitis, 9th World Congress of Itch, October 16, 2017. [View Poster]

March 2015 press release announcing Phase II study (2101) results. Vanda Pharmaceuticals Announces Tradipitant Phase II Proof of Concept Study Results for Chronic Pruritus in Atopic Dermatitis [View Press Release ]

To learn more about tradipitant clinical trials [View Clinicaltrials.gov]

References

  1. National Eczema Association (2017)
  2. Decision Resource Group, Atopic Dermatitis Landscape and Forecast (November 2015)
  3. George DT, Gilman J, Hersh J, Thorsell A, Herion D, Geyer C, Peng X, Keilbasa W, Rawlings R, Brandt JE, Gehlert DR, Tauscher JT, Hunt SP, Hommer D, Heilig M. Neurokinin 1 receptor antagonism as a possible therapy for alcoholism. Science. 2008; 319(5869):1536-9
  4. Almeida TA, Rojo J, Nieto PM, Pinto FM, Hernandez M, et al. Tachykinins and tachykinin receptors: structure and activity relationships. Current Medicinal Chemistry. 2004;11:2045-2081.
  5. Hargreaves R, Ferreira JC, Hughes D, Brands J, Hale J, Mattson B, Mill S. Development of aprepitant, the first neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting. Annals of the New York Academy of Sciences. 2011; 1222:40-48.
  6. Stander S, Weisshaar E, Luger A. Neurophysiological and neurochemical basis of modern pruritus treatment. Experimental Dermatology. 2007;17:161-69.
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