Nektar Therapeutics’ shares took an upward turn after Sanofi unveiled preliminary results from its Phase 3 trial for its monoclonal antibody treatment for atopic dermatitis, amlitelimab. The reported outcomes, viewed as significantly below the expected efficiency threshold, also led to a surge in Regeneron’s stocks.
Amlitelimab is an entirely human, non-T cell eliminating monoclonal antibody, devised to focus on the OX40-ligand. As per the worldwide COAST 1 phase 3 study findings, doses administered every four or twelve weeks managed to meet key primary and secondary efficacy objectives, thereby revealing significant and clinically relevant improvements in skin clarity and disease gravity compared with a placebo at Week 24.
The trial included patients who were 12 years or older and were suffering from moderate to severe atopic dermatitis. The performance of amlitelimab was observed to be satisfactory, with no new safety-related issues reported during this trial.
Study endpoints were evaluated at Week 24 for patients who were administered amlitelimab either every four weeks or every twelve weeks. For the United States and countries with comparable medical standards, the primary objective was to calculate the percentage of patients showing a decrease by 2 or more points from the initial score on an approved investigator global assessment scale for atopic dermatitis.
Both treatment strategies showed a continuous improvement in efficacy over the treatment duration, with no signs of reaching a plateau. Additionally, the key secondary objectives of the study were fulfilled by both dosage regimes by Week 24.
Secondary targets included the proportion of patients obtaining a vIGA-AD 0/1, barely discernible erythema along with a reduction of 2 or more points from the baseline, and the proportion of patients who managed to achieve a reduction of 4 or more points in the peak pruritus-numerical rating scale if their baseline PP-NRS was 4 or above.
The most frequent treatment-related adverse events in the COAST 1 study were atopic dermatitis, nasopharyngitis, and upper respiratory tract infections. However, these events were more prevalent in the control set compared to those treated with amlitelimab. The number of injection site reactions was slightly higher in the amlitelimab groups; however, the reactions were mild and all patients recovered, with treatment continuation in every instance.
The incidents of fever and chills were recorded to be minimal. The overall rates of emerging treatment-related negative events, serious adverse events, and TEAEs resulting in treatment discontinuation remained close to those observed in the placebo group and in the combined amlitelimab groups.
Sanofi’s amlitelimab is currently part of a five-study phase 3 trial, dubbed the OCEANA program, with additional readouts expected up until 2026.
Piper Sandler, in reviewing the released data, emphasized that the demonstrated efficacy of Sanofi’s amlitelimab in the Phase 3 COAST 1 trial among patients with moderate to severe atopic dermatitis was fairly lackluster when contrasted with Nektar’s REZPEG Phase 2b REZOLVE-AD.
The firm further contended that this highlights and bolsters REZPEG’s unique characteristics, thus securing its appeal and potential in the competitive marketplace surrounding inflammatory diseases. Accordingly, Piper remains largely supportive and optimistic about Nektar’s future prospects.
Following the release of the phase 3 trial results, Sanofi’s shares have taken a nearly 9% fall to $45.63. Meanwhile, Nektar’s stock has seen a substantial boost, showing an approximated increase of 20% with the current value standing at $34.10.
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