Sanofi, a leading French pharmaceutical company, has reported positive results from the second segment of the amlitelimab Phase 2b study STREAM-AD. The study provided promising evidence of sustained symptom improvement in adults with moderate to severe atopic dermatitis, who had previously responded to amlitelimab.
Patients who continued with the treatment displayed high responder rates over 28 weeks, as did those who had stopped taking amlitelimab. The data indicates that amlitelimab was well-tolerated, with no new safety issues discovered, maintaining the safety profile seen in the first part of the study.
These results support the ongoing investigation into a larger Phase 3 clinical program, OCEANA, utilizing a quarterly dosage of 250 mg amlitelimab with a 500 mg loading dose.
During the second part of the STREAM-AD study, patients with a 75% improvement in Eczema Area and Severity Index (EASI-75) and/or Investigator Global Assessment (IGA) score of 0 or 1 after 24 weeks of treatment were examined to see if they could maintain this clinical response after an additional 28-week period with continued or withdrawn amlitelimab treatment.
Patients who continued with the treatment managed to maintain a high EASI-75 and/or IGA score, with high response rates also observed in patients who stopped treatment. Among the patients who continued the treatment with a 250 mg dose of amlitelimab every four weeks with a 500 mg loading dose, 69.2% maintained their IGA and/or EASI-75 response, compared to 58.8% of patients who stopped treatment.
Analyses that included all dosage levels showed that 71.9% and 69% of patients who continued treatment maintained their IGA and EASI-75 responses, respectively, compared with 57% and 61.6% of patients who stopped treatment.
Sanofi pointed out that the continued reduction of biomarkers suggests that the drug may control the disease long-term via the inhibition of OX40L, a non-T cell depleting mechanism, indicating immune response modulation.
