(News Bulletin 247) – The pharmaceutical group has published results of clinical trials evaluating amlitelimab to treat atopic dermatitis, a form of eczema. This drug should constitute one of the group’s future growth drivers.

Sanofi’s pipeline of drug candidates continues to make advances in clinical trials.

The pharmaceutical group thus delivered this Tuesday new phase II results (intermediate stage of clinical trials before phase III which marks the last stage before potential marketing) for amlitelimab.

The study called “Stream-Ad” evaluates this molecule in the treatment of atopic dermatitis, also called “atopic eczema”. This chronic inflammatory disease is characterized by itching and mainly affects children but it can persist into adulthood. It can cause skin lesions or even infections.

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Sustainable efficiency

The results of the clinical trial show “sustained improvement in the signs and symptoms of moderate to severe atopic dermatitis for 28 weeks in adults who had previously responded to amlitelimab and continued their treatment,” explains Sanofi.

Response rates were 69.2% among patients who continued treatment with a dose of 250 milligrams of amlitelimab every four weeks. “Interestingly, high response rates were also observed among participants who had stopped receiving amlitelimab,” Invest Securities points out. This rate actually rose to 58.8% for patients who had stopped treatment.

“The results of this part of the study indicate that amlitelimab has the potential to show sustained efficacy after interruption of its administration, which justifies the evaluation of a less frequent dosing schedule, at a dose every every 12 weeks. This regimen could represent an important benefit for patients with atopic dermatitis,” explained Professor Sephan Weidinger, director of the department of dermatology and allergology at the University Hospital of Schleswig-Holstein, quoted in the press release. from Sanofi.

“This type of durable response is unprecedented and we believe could be of great benefit to patients. For this reason, we chose to study an every 12-week dosing regimen in the pivotal atopic dermatitis program. “, declared Naimish Patel, global head of development, immunology and inflammation at Sanofi, also quoted in the press release.

On the Paris Stock Exchange, these announcements provide some support for Sanofi shares, which rose 1.1% around 10:50 a.m., which constitutes the strongest increase in the CAC 40.

An important weight in Sanofi’s strategy

Sanofi took an important turn last fall. The pharmaceutical group announced a new strategic plan with an increase in R&D spending to launch innovative new drugs and vaccines. Which had also shocked the market, with Sanofi shares losing nearly 19% over one session. The group then warned that increased R&D spending (combined with negative tax impacts) would lead it to publish a decline in its earnings per share in 2024 when the consensus expected clear growth.

The group is banking on several experimental treatments to stimulate its growth and reduce its dependence on its blockbuster Dupixent, whose sales should continue to grow by more than 10% per year by 2030. According to UBS, sales of Dupixent should thus be increase to 21.5 billion euros by this time (compared to 10.7 billion in 2023).

The group has identified twelve drug candidates whose sales could exceed 5 billion euros in revenue at cruising speed.

Amlitelimab constitutes one of these potential blockbusters. Sanofi expects to submit this drug for approval to health authorities in 2027 for atopic dermatitis. The group has also started clinical trials to evaluate this molecule in the treatment of asthma as well as for hidradenitis suppurativa, a skin condition that resembles acne. Sanofi is also evaluating the potential of amlitelimab in scleroderma (a chronic disease with abnormal thickening of the skin), celiac disease (gluten intolerance) and alopecia (hair loss), with Phase II initiations planned for 2024.