Amlitelimab, dosed every four weeks or every 12 weeks, demonstrated statistically significant and clinically meaningful efficacy in skin clearance and disease severity compared to placebo at week 24, the company said.
Sanofi (SNY) announced on Thursday that its experimental drug, Amlitelimab, met all primary and key secondary endpoints in a late-stage study in adults and adolescents with atopic dermatitis (AD).
The study enrolled 601 adults and adolescents aged 12 years and older with moderate-to-severe AD. Amlitelimab, dosed every four weeks or every 12 weeks, demonstrated statistically significant and clinically meaningful efficacy in skin clearance and disease severity compared to placebo at week 24. Furthermore, a progressive increase in efficacy was observed during the treatment period in patients who were dosed every four weeks as well as in those who were dosed every 12 weeks, the company said.
The most common treatment-emergent adverse events, such as upper respiratory tract infection, were more common in the placebo arm compared to the Amlitelimab-treated arms of the study, it said.
Shares of the company, however, traded 9% lower in the premarket session at the time of writing.
According to a Reuters report, Jefferies analysts opined that the trial results fell short of those from an earlier trial and of rival biologic drugs. However, the drug’s safety profile and convenient 12-week dosing regimen could still support its use.
JPMorgan, meanwhile, noted that the data confirmed that Amlitelimab is less effective than Sanofi’s approved drug Dupixent, Reuters added. On Stocktwits, retail sentiment around SNY stock jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘high’ levels.
Sanofi’s Dupixent is approved to treat atopic dermatitis in addition to asthma, chronic spontaneous urticaria, and other diseases. In the second quarter, Dupixent sales increased by 21.1% to €3.8 billion ($4.43 billion), and the company was expecting Amlitelimab to complement the blockbuster drug.
The firm now looks forward to sharing additional late-stage results from the clinical development program of Amlitelimab in atopic dermatitis, said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi.
SNY stock is up 3% this year but down approximately 15% over the past 12 months.
Read also: FDA Says No Advisory Committee Meeting Needed For Aquestive’s Oral Epinephrine Film
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
Exchange Rate: €1= $1.17<