Sanofi says amlitelimab met primary, key secondary endpoints in Phase 3 study

Results from the global COAST 1 phase 3 study showed that amlitelimab, a fully human non-T cell depleting monoclonal antibody that targets OX40-ligand, dosed either every four weeks or every 12 weeks, met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to placebo at Week 24 in patients aged 12 years and older with moderate-to-severe atopic dermatitis, Sanofi (SNY) said in a statement. Amlitelimab was well-tolerated, with no new safety concerns identified in this study, Sanofi said. The key endpoints were measured at Week 24 in patients who received amlitelimab either Q4W or Q12W. For US and US reference countries, the primary endpoint was the proportion of patients with a validated investigator global assessment scale for AD of 0 or 1 and a reduction from baseline score of greater than or equal to2 points. In both treatment arms, a progressive increase in efficacy without plateau was observed during the treatment period. The study’s key secondary endpoints were also achieved across both dosing arms at Week 24, including the proportion of patients who achieved a vIGA-AD 0/1 with only barely perceptible erythema and a reduction from baseline of greater than or equal to2-points, and the proportion of patients who achieved a greater than or equal to4-point reduction in peak pruritus-numerical rating scale from baseline in patients with a baseline PP-NRS greater than or equal to 4. The most common treatment emergent adverse events in COAST 1 were AD, nasopharyngitis and upper respiratory tract infection. All were more common in the placebo arm compared to amlitelimab-treated arms. Injection site reactions were numerically higher in amlitelimab arms. All were mild, patients recovered, and study medication was continued in all cases. Rates of pyrexia and chills were low. Overall, rates of treatment-emergent adverse events, serious adverse events, and TEAEs resulting in treatment discontinuation were similar in the placebo arm and pooled amlitelimab arms. The OCEANA clinical development program of amlitelimab in AD, which includes COAST 1 and four other phase 3 studies is anticipated to read out through 2026 and comprises the foundation for potential global regulatory submissions.