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INCYTE CORPORATION

(INCY)
  Report
Delayed Nasdaq  -  04:00:01 2023-03-21 pm EDT
73.49 USD   -0.98%
03/20SVB Securities Adjusts Price Target on Incyte to $60 From $63, Keeps Underperform Rating
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03/18Transcript : Incyte Corporation - Special Call
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03/18Incyte : Povorcitinib in Vitiligo Oral Presentation (AAD)
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Incyte : Povorcitinib in Vitiligo Oral Presentation (AAD)

03/18/2023 | 03:57pm EDT

Presented at the American Academy of Dermatology (AAD) Annual Meeting

March 17-21, 2023; New Orleans, LA

Efficacy and Safety of Povorcitinib for Extensive Vitiligo: Results From a

Double-Blinded,Placebo-Controlled,Dose-Ranging Phase 2b Study

Amit G. Pandya, MD,1,2 Khaled Ezzedine, MD, PhD,3 Thierry Passeron, MD, PhD,4,5

Nanja van Geel, MD, PhD,6 Kurt Brown, MD,7 Leandro Santos, MSc,7 Lois Erskine, PhD,7

Kofi Wagya, PhD,7 Andrew Blauvelt, MD, MBA8

1University of Texas Southwestern Medical Center, Dallas, TX, USA; 2Palo Alto Foundation Medical Group, Sunnyvale, CA, USA; 3Henri Mondor University

Hospital and Université Paris-Est Créteil Val de Marne, Paris, France; 4Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France;

5INSERM U1065, C3M, Université Côte d'Azur, Nice, France; 6Ghent University Hospital, Ghent, Belgium; 7Incyte Corporation, Wilmington, DE, USA;

8Oregon Medical Research Center; Portland, OR, USA

1

Presenting Author Disclosures

  • Investigator for Aclaris Therapeutics, Immune Tolerance Network, Incyte, and Pfizer
  • Consultant for AbbVie, Arcutis, Avita Medical, Chromaderm, Immune Tolerance Network, Incyte, Pfizer, TWi, Viela Bio, and Villaris
  • Holds stock options for Tara Medical and Zerigo Health

2

Background

  • Vitiligo is a chronic autoimmune disease that targets melanocytes, resulting in patches of skin depigmentation1
  • Disease pathogenesis is largely regulated by interferon-γ activation of the JAK signaling pathway2
  • Povorcitinib is an oral, small-molecule, selective JAK1 inhibitor with potential activity in the treatment of nonsegmental vitiligo
  • Objective: To evaluate the efficacy and safety of povorcitinib in patients with extensive nonsegmental vitiligo in a phase 2b trial (NCT04818346)

JAK, Janus kinase.

1. Rodrigues M, et al. J Am Acad Dermatol. 2017;77(1):1-13.2. Rashighi M, Harris JE. Ann Transl Med. 2015;3(21):343.

3

Study Design (NCT04818346)

Patient population:

  • Adults 18-75 years old
  • Nonsegmental vitiligo
  • Vitiligo-affectedBSA*:
    • Total body ≥8%
    • Face ≥0.5%
  • VASI score:
    • T-VASI≥8
    • F-VASI≥0.5

Efficacy assessments:

  • % change from baseline in T-VASI
  • % patients achieving T-VASI50,F-VASI50, and F-VASI75

Safety assessments:

Incidence of TEAEs

Placebo-Controlled Period

Extension Period

Follow-Up Period

(24 weeks)

(28 weeks)

(24 weeks)

Randomized

Completed

Treated

Completed

n=43

Povorcitinib 45 mg qd

33

32

Povorcitinib 45 mg qd

27

n=42

35

34

29

Povorcitinib 75 mg qd

Post-Treatment

n=43

Povorcitinib 15 mg qd

38

37

Povorcitinib 75 mg qd

30

n=43

Placebo qd

35

35

33

Week

24

36

52 56

76

Day 1

Visits every 4 weeks

Visits every 4 weeks

Primary endpoint

Interim data lock

BSA, body surface area; F-VASI, facial VASI; F-VASI50/75, ≥50%/≥75% reduction from baseline in F-VASI; qd, once daily; TEAE, treatment-emergent adverse event; T-VASI, total VASI;

T-VASI50, ≥50% reduction from baseline in T-VASI; VASI, Vitiligo Area Scoring Index.

* Total and facial BSA were locally assessed. Week 24 assessment was the primary endpoint.

4

Patient Demographics and

Clinical Characteristics at Baseline

Povorcitinib

Placebo

15 mg

45 mg

75 mg

Total

Characteristic

(n=43)

(n=43)

(n=43)

(n=42)

(N=171)

Age,

51.0

45.0

51.0

52.5

50.0

median (range), y

(24-72)

(23-67)

(25-72)

(24-74)

(23-74)

Female, n (%)

24

29

21

19

93

(55.8)

(67.4)

(48.8)

(45.2)

(54.4)

Race, n (%)

White

34

32

38

28

132

(79.1)

(74.4)

(88.4)

(66.7)

(77.2)

Asian

2

4

0

7

13

(4.7)

(9.3)

(16.7)

(7.6)

Black

2

3

1

3

9

(4.7)

(7.0)

(2.3)

(7.1)

(5.3)

Hispanic, n (%)

8

6

11

7

32

(18.6)

(14.0)

(25.6)

(16.7)

(18.7)

Fitzpatrick skin type,

n (%)

I-III

28

26

35

25

114

(65.1)

(60.5)

(81.4)

(59.5)

(66.7)

IV-VI

15

17

8

17

57

(34.9)

(39.5)

(18.6)

(40.5)

(33.3)

Povorcitinib

Placebo

15 mg

45 mg

75 mg

Total

Characteristic

(n=43)

(n=43)

(n=43)

(n=42)

(N=171)

Baseline F-VASI,

1.5

1.3

1.3

1.1

1.3

mean (SD)

(0.8)

(0.8)

(0.8)

(0.7)

(0.8)

Baseline T-VASI,

28.3

27.1

23.6

22.7

25.5

mean (SD)

(21.5)

(20.1)

(19.8)

(14.2)

(19.1)

Duration of disease,

19.5

17.6

19.9

20.5

19.4

mean (SD), y

(14.0)

(13.0)

(15.5)

(13.7)

(14.0)

Family history of

15

9

11

14

49

vitiligo, n (%)

(34.9)

(20.9)

(25.6)

(33.3)

(28.7)

Thyroid disorders,

11

12

12

12

47

n (%)

(25.6)

(27.9)

(27.9)

(28.6)

(27.5)

Previous therapy,*

n (%)

Topical

18

24

21

25

88

corticosteroid

(41.9)

(55.8)

(48.8)

(59.5)

(51.5)

Topical calcineurin

14

13

17

20

64

inhibitor

(32.6)

(30.2)

(39.5)

(47.6)

(37.4)

Any phototherapy

20

17

13

27

77

(46.5)

(39.5)

(30.2)

(64.3)

(45.0)

* Patients could have used multiple previous lines of therapy.

5

Disclaimer

Incyte Corporation published this content on 18 March 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 March 2023 19:56:03 UTC.


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Net income 2023 653 M - -
Net cash 2023 3 454 M - -
P/E ratio 2023 25,9x
Yield 2023 -
Capitalization 16 386 M 16 386 M -
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