Sanofi’s ‘disappointing’ atopic dermatitis data sends Nektar higher

Shares of Nektar Therapeutics (NKTR) jumped on Thursday after Sanofi reported the first headline data for amlitelimab from its first Phase 3 trial in atopic dermatitis, which was seen as “well below” the expected bar for efficacy. The news also sent shares of Regeneron (REGN) trading higher.

AD DATA: 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 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 U.S. and U.S. 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 to 2 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 to 2-points, and the proportion of patients who achieved a greater than or equal to 4-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.

EFFICACY WELL BELOW: Commenting on Sanofi’s first headline data for amlitelimab from its first Phase 3 trial in atopic dermatitis, BofA analyst Sachin Jain said that though the study met its primary and secondary endpoints, the data was “well below” the expected bar for efficacy. The firm, which expects shares to trade down following the release, sees “a quieter pipeline path” with “smaller” Phase 3 read-outs in FY25. The firm maintains a Buy rating on Sanofi.

DISAPPOINTING RESULTS: Raymond James maintained an Outperform rating on Regeneron shares and a Market Perform rating on Amgen (AMGN) after Sanofi reported “disappointing” data for its amlitelimab COAST 1 Phase 3 trial in atopic dermatitis trial. Placebo-adjusted EASI-75 generally conferred a 20% placebo-adjusted EASI-75 benefit, which is very similar to Amgen’s “disappointing” OX40 rocatinlimab but much lower than Dupixent’s 36% placebo-adjusted EASI-75 bar. Raymond James noted that while investors seem disappointed, doctors were already there with a recent survey indicating a general lack of enthusiasm regarding the new mechanism. The firm expected Regeneron shares to be higher on Thursday.

DIFFERENTIATED PROFILE: Piper Sandler notes that Sanofi’s released data from amlitelimab’s Phase 3 COAST 1 in moderate-to-severe atopic dermatitis patients demonstrated relatively underwhelming efficacy compared to Nektar’s REZPEG Phase 2b REZOLVE-AD. Ultimately, the firm believes this reiterates REZPEG’s differentiated profile, further substantiating its competitive commercial potential across inflammatory diseases. Hence, Piper remains bullish on Nektar and sees a buying opportunity into a catalyst-rich year into data from REZOLVE-AD escape arm, 36-week maintenance, and REZOLVE-AA. The firm has an Overweight rating on Nektar with a price target of $105 on the shares.

PRICE ACTION: In afternoon trading, shares of Sanofi are down almost 9% at $45.63, while Nektar’s stock is up about 20% at $34.10.