Nemluvio

Question 1

IL-31 producing cells

Answer 1

Dendritic cells
Macrophages
Mast cells
Basophils
Eosinophils
Th2 cells

Question 2

IL-31RA expressing cells

Answer 2

Sensory nerve endings & DRG
Keratinocytes
Fibroblasts
Eosinophils
Basophils
Macrophages
Dendritic cells

Question 3

To form the IL-31 receptor, Interleukin 31 receptor A heterodimerizes with

Answer 3

Oncostatin-M specific receptor subunit beta

Question 4

IL-31 drives

Answer 4

Itch - Nerve activation, thickening, elongation & branching

Inflammation - induces additional chemokines & cytokines

Barrier dysfunction - disrupts normal keratinocyte differentiation

Fibrosis - triggers tissue remodeling

Question 5

Nemluvio blocks

Answer 5

Signals in nerves & DRG
Inflammation
Keratinocyte dysfunction
Pro-fibrotic responses

Question 6

Largest controlled clinical trial program in PN to date

Answer 6

Olympia

Question 7

Inclusion criteria

Answer 7

Avg itch >= 7
nodules >= 20
IGA >= 3

Question 8

Exclusion criteria

Answer 8

Neuropathic pruritus
Psychogenic pruritus
Other condition pruritus
Active AD in last 3 mos

Question 9

Primary endpoints

Answer 9

4 pt itch improvement
Clear/Almost clear
at wk 16

Question 10

Secondary endpoints

Answer 10

4 pt Itch improvement @ wk 4
Itch < 2 @ wk 4 & 16

4 pt sleep imp @ wk 4 & 16

Question 11

Patient characteristics

Answer 11

Almost as many severe as moderate (44 & 56%)
Avg itch 8.5
1/3 > 100 nodules
>7 sleep disturbance
Most had daily pain > 7
DLQI 17/30
Some anxiety/depression
1/3 had background atopy
1/2 failed systemic therapy

Question 12

Vixarelimab

Answer 12

Investigational IL-31 blocker that binds to oncostatin M receptor beta in the Genentech pipeline for idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease

Question 13

LTE pt characteristics

Answer 13

Same as lead-in studies
(Predominantly overweight middle aged white women)

Question 14

4 pt itch reduction &
IGA 0/1
at 16 wks

Answer 14

> 50%
1/3
(both 3x placebo)

Question 15

4+ improvement of itch at 1 yr

Answer 15

> 80%

Question 16

Clinically significant itch relief at

Answer 16

48 hrs

Question 17

5x as many pts w/ 4+ itch relief at

Answer 17

Wk 1 vs placebo

Question 18

Avg itch < 2 at
Wk 4
Wk 16
1 yr

Answer 18

> 20% (10x placebo)

Almost 1/3

Almost 70%

Question 19

4+ sleep improvement by weeks 4 & 16

Answer 19

1/3 by wk 4
1/2 by wk 16

Question 20

clear or almost clear by wk 16

Answer 20

Almost 40%
(3.5x placebo)

Question 21

75% clear at wk 16

Answer 21

Over half
(3x placebo)

Question 22

75% healed at 1 yr

Answer 22

> 80%

Question 23

Significant quality of life improvement at wk 16

Answer 23

75%

Question 24

Anxiety & depression at wk 16

Answer 24

Significantly less

Question 25

DLQI 0/1 after 1 yr

Answer 25

Half

Question 26

Rated treatment good to excellent at wk 16

Answer 26

70%
(Vs 26% placebo)

Question 27

Headache

Answer 27

6%
(vs 3% placebo)

Question 28

4% atopic dermatitis d/t

Answer 28

Immune phenotype switching

Question 29

Discontinued d/t AEs

Answer 29

4%
(vs 3% placebo)

Question 30

Arthralgia, conjunctivitis & injection site reactions

Answer 30

None

Question 31

Increased dose

Answer 31

198+ lbs

Question 32

Can be stored at room temp for up to

Answer 32

90 days

Question 33

Master cytokine of PN

Answer 33

IL-31