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Monday, September 27, 2021

Aslan fails to roar with atopic dermatitis data

 Dupixent has set such a high bar in atopic dermatitis anyone coming for its crown had better come prepared. This could be why questions around Aslan Pharmaceuticals' trial design and results contributed to a 31% fall in the group’s share price. In the phase 1 trial a 600mg dose of ASLAN004 showed a statistically significant 65% change in skin clearance from baseline at week 8. However, there were concerns about the removal of nine patients from the original intent-to-treat population and the study using a one-sided p value. Perhaps more worrying was that the number of patients achieving a IGA score of 0/1, ie clear or almost clear skin, was not significant at 48.3% versus 15.4% for placebo (p=0.107); this is important as the IGA 0/1 score is used for US approval. Arguably the sample size of 29 – reduced from 38 – was not powered to show a definitive result, but the result also appeared to show reduced efficacy; in March 22% of patients achieved IGA or 0/1, compared with 0% on placebo. Aslan is looking to begin a phase 2 trial before the end of the year and one concern is that what looks like waning efficacy could be exacerbated with larger numbers.

ASLAN004 phase 1 trial
Endpoint (8 weeks)RITT (n=29)ITT (n=38)
 600mgPlacebop-value1600mgPlacebop-value1
 (n=16)(n=13) (n=22)(n=16) 
Mean % change from baseline in EASI-64.9-27.20.021-61.3-31.90.023
EASI-50 (%)81.330.80.00877.337.50.016
EASI-75 (%)68.815.40.0055012.50.018
EASI-90 (%)37.515.40.18327.312.50.245
IGA 0/1 (%)43.815.40.10731.818.80.301
Mean % change from baseline in peak pruritus-38.6-15.30.051-37.1-15.70.032
RITT = revised intent to treat; p-value1 (one-sided p-value). Source: Company announcement.

https://www.evaluate.com/vantage/articles/news/snippets/aslan-fails-roar-atopic-dermatitis-data

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