Sanofi (SNY - Free Report) announced that the mid-stage study evaluating pipeline candidate amlitelimab for moderate-to-severe atopic dermatitis in adults met the primary endpoint.
Amlitelimab is a fully human, non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator.
STREAM-AD, a phase IIb study, was a randomized, double-blind, placebo-controlled study evaluating amlitelimab in adult patients with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with topical therapies or where such therapies were not advisable.
The primary endpoint was the percentage change in Eczema Area and Severity Index (EASI) from baseline at 16 weeks. Key secondary endpoints included change in EASI from baseline at 24 weeks, percentage of patients with at least a 75% reduction from baseline in EASI at 16 and 24 weeks, percentage of patients with a response of IGA 0 (clear) or 1 (almost clear) and a reduction from baseline ≥ 2 points at 16 and 24 weeks and proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 with baseline pruritus of ≥ 4 from baseline at 16 and 24 weeks.
Data from this dose-ranging study showed that treatment with amlitelimab resulted in statistically significant improvements in average EASI score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied.
Data also showed improvements in key secondary outcome measures. The candidate was well tolerated in the study across all dose arms and no new safety concerns were identified.
The biomarker results also support an effect on both type 2 and non-type 2 pathways.
Encouraging results from this study support Sanofi’s perspective that targeting OX40-Ligand has the potential to provide a first- and best-in-class treatment option that addresses type 2 and non-type 2 inflammation in atopic dermatitis and other chronic inflammatory diseases. The company now looks forward to advancing the candidate in phase III.
Sanofi’s stock has gained 11.3% this year so far compared with the industry’s gain of 0.7%.
The successful development of amlitelimab will broaden Sanofi’s immunology portfolio.
Please note that Sanofi’s Dupixent is already approved for atopic dermatitis.
Dupixent is being jointly marketed by Sanofi and partner Regeneron (REGN - Free Report) under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The drug is currently approved in the United States and Europe for type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Dupixent has become the key driver of the top line for both Regeneron and Sanofi.
Zacks Rank and Stocks to Consider
Sanofi currently has a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) .
LGND currently sports a Zacks Rank #1 (Strong Buy) and NVS carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.60 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Sanofi (SNY - Free Report) announced that the mid-stage study evaluating pipeline candidate amlitelimab for moderate-to-severe atopic dermatitis in adults met the primary endpoint.
Amlitelimab is a fully human, non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator.
STREAM-AD, a phase IIb study, was a randomized, double-blind, placebo-controlled study evaluating amlitelimab in adult patients with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with topical therapies or where such therapies were not advisable.
The primary endpoint was the percentage change in Eczema Area and Severity Index (EASI) from baseline at 16 weeks. Key secondary endpoints included change in EASI from baseline at 24 weeks, percentage of patients with at least a 75% reduction from baseline in EASI at 16 and 24 weeks, percentage of patients with a response of IGA 0 (clear) or 1 (almost clear) and a reduction from baseline ≥ 2 points at 16 and 24 weeks and proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 with baseline pruritus of ≥ 4 from baseline at 16 and 24 weeks.
Data from this dose-ranging study showed that treatment with amlitelimab resulted in statistically significant improvements in average EASI score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied.
Data also showed improvements in key secondary outcome measures. The candidate was well tolerated in the study across all dose arms and no new safety concerns were identified.
The biomarker results also support an effect on both type 2 and non-type 2 pathways.
Encouraging results from this study support Sanofi’s perspective that targeting OX40-Ligand has the potential to provide a first- and best-in-class treatment option that addresses type 2 and non-type 2 inflammation in atopic dermatitis and other chronic inflammatory diseases. The company now looks forward to advancing the candidate in phase III.
Sanofi’s stock has gained 11.3% this year so far compared with the industry’s gain of 0.7%.
The successful development of amlitelimab will broaden Sanofi’s immunology portfolio.
Please note that Sanofi’s Dupixent is already approved for atopic dermatitis.
Dupixent is being jointly marketed by Sanofi and partner Regeneron (REGN - Free Report) under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The drug is currently approved in the United States and Europe for type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Dupixent has become the key driver of the top line for both Regeneron and Sanofi.
Zacks Rank and Stocks to Consider
Sanofi currently has a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) .
LGND currently sports a Zacks Rank #1 (Strong Buy) and NVS carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.60 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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