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ASLAN (ASLN) Starts Phase IIb Study in Atopic Dermatitis
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ASLAN Pharmaceuticals (ASLN - Free Report) announced the initiation of a phase IIb study (TREK-AD study) evaluating its IL-13 inhibitor, eblasakimab (formerly ASLAN004), in patients with atopic dermatitis (AD), also called eczema.
The TREK-AD study is a dose ranging study designed to evaluate the safety and efficacy of eblasakimab in adult patients with moderate-to-severe AD over a 16-week treatment period and a 12-week safety follow-up period.
The TREK-AD study will enroll approximately 300 adult participants across multiple countries. ASLAN will then randomize the participants equally in four treatment arms evaluating four different doses of eblasakimab (300mg every two weeks, 400mg every two weeks, 400mg every four weeks and 600mg every four weeks) and a fifth arm that will evaluate treatment in participants with placebo.
ASLAN expects to report top-line data from the study in first-half 2023.
The primary efficacy endpoint of the TREK-AD study is the percentage change in the Eczema Area Severity Index (EASI) score from baseline to week 16, with statistically significant improvements in key secondary efficacy endpoints like EASI-75, EASI-50, EASI-90, IGA score of 0 (clear) or 1 (almost clear) and changes in peak pruritus.
Shares of ASLAN have declined 57% in the past year in comparison with the industry’s 38.1% decline.
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The phase IIb study is based on positive data from the phase Ib multiple-ascending-dose study, which supported eblasakimab as a novel treatment for AD. Last September, ASLAN reported that the phase Ib study achieved its primary efficacy endpoint of percentage change in EASI score in an eight-week treatment period. Treatment with eblasakimab demonstrated a significant improvement of 61% in comparison to treatment with placebo, which demonstrated an improvement of 32%. The study also achieved improvement in other key efficacy endpoints.
Eblasakimab is an investigational monoclocal antibody designed to target IL-13, a key driver of inflammation in AD.
Apart from eblasakimab, the company is also planning to start a phase II study in first-half 2022 evaluating ALSAN003 in inflammatory bowel disease.
We note that the AD market targeted by the company is highly competitive as many pharma giants are already marketing their own AD medications.
If approved, ASLAN will face stiff competition from Regeneron (REGN - Free Report) and partner Sanofi’s (SNY - Free Report) monoclonal antibody, which is approved to treat AD.
Dupilumab is marketed by Regeneron/Sanofi under the trade name Dupixent, which is approved by the FDA to treat moderate-to-severe AD in patients aged six years and older.
BioNTech’s earnings per share estimates for 2022 have increased from $31.14 to $32.72 in the past 60 days. Shares of BioNTech have risen 48.5% in the past year.
Earnings of BioNTech beat estimates in all the last four quarters, delivering a surprise of 132.4%, on average.
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ASLAN (ASLN) Starts Phase IIb Study in Atopic Dermatitis
ASLAN Pharmaceuticals (ASLN - Free Report) announced the initiation of a phase IIb study (TREK-AD study) evaluating its IL-13 inhibitor, eblasakimab (formerly ASLAN004), in patients with atopic dermatitis (AD), also called eczema.
The TREK-AD study is a dose ranging study designed to evaluate the safety and efficacy of eblasakimab in adult patients with moderate-to-severe AD over a 16-week treatment period and a 12-week safety follow-up period.
The TREK-AD study will enroll approximately 300 adult participants across multiple countries. ASLAN will then randomize the participants equally in four treatment arms evaluating four different doses of eblasakimab (300mg every two weeks, 400mg every two weeks, 400mg every four weeks and 600mg every four weeks) and a fifth arm that will evaluate treatment in participants with placebo.
ASLAN expects to report top-line data from the study in first-half 2023.
The primary efficacy endpoint of the TREK-AD study is the percentage change in the Eczema Area Severity Index (EASI) score from baseline to week 16, with statistically significant improvements in key secondary efficacy endpoints like EASI-75, EASI-50, EASI-90, IGA score of 0 (clear) or 1 (almost clear) and changes in peak pruritus.
Shares of ASLAN have declined 57% in the past year in comparison with the industry’s 38.1% decline.
The phase IIb study is based on positive data from the phase Ib multiple-ascending-dose study, which supported eblasakimab as a novel treatment for AD. Last September, ASLAN reported that the phase Ib study achieved its primary efficacy endpoint of percentage change in EASI score in an eight-week treatment period. Treatment with eblasakimab demonstrated a significant improvement of 61% in comparison to treatment with placebo, which demonstrated an improvement of 32%. The study also achieved improvement in other key efficacy endpoints.
Eblasakimab is an investigational monoclocal antibody designed to target IL-13, a key driver of inflammation in AD.
Apart from eblasakimab, the company is also planning to start a phase II study in first-half 2022 evaluating ALSAN003 in inflammatory bowel disease.
We note that the AD market targeted by the company is highly competitive as many pharma giants are already marketing their own AD medications.
If approved, ASLAN will face stiff competition from Regeneron (REGN - Free Report) and partner Sanofi’s (SNY - Free Report) monoclonal antibody, which is approved to treat AD.
Dupilumab is marketed by Regeneron/Sanofi under the trade name Dupixent, which is approved by the FDA to treat moderate-to-severe AD in patients aged six years and older.
ASLAN Pharmaceuticals Ltd. Price
ASLAN Pharmaceuticals Ltd. price | ASLAN Pharmaceuticals Ltd. Quote
Zacks Rank & Key Pick
ASLAN carries a Zacks Rank #3 (Hold) at present. A better-ranked stock in the same sector is BioNTech (BNTX - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
BioNTech’s earnings per share estimates for 2022 have increased from $31.14 to $32.72 in the past 60 days. Shares of BioNTech have risen 48.5% in the past year.
Earnings of BioNTech beat estimates in all the last four quarters, delivering a surprise of 132.4%, on average.