Sanofi's bispecific lunsekimig has mixed readouts in phase 2
A bispecific antibody that Sanofi thinks could be a future star of its immunology and inflammation business has hit the mark in two midstage trials in respiratory indications, but fallen short in a third in atopic dermatitis.
On the plus side, lunsekimig – which simultaneously targets IL-13 and TSLP – met its primary objectives in the phase 2b AIRCULES asthma trial and phase 2a DUET study in chronic rhinosinusitis with nasal polyps (CRSwNP).
However, the phase 2b trial in moderate-to-severe atopic dermatitis missed its primary endpoint, according to Sanofi, although it should be noted this has been viewed as an exploratory indication for lunsekimig.
The company has been focusing mainly on respiratory indications for lunsekimig, and its phase 3 programme for the drug includes the PERSEPHONE and the THESEUS studies in chronic obstructive pulmonary disease (COPD), with a phase 2b study (AIRLYMPUS) also underway in high-risk asthma.
Lunsekimig is one of a trio of clinical candidates that Sanofi is developing as successors to its big-selling IL-3 and IL-13 inhibitor Dupixent (dupilumab), partnered with Regeneron, which brought in nearly $18 billion last year, but could start to lose patent protection in some markets in the early 2030s.
The French group has particularly high hopes for anti-OX40L antibody amlitelimab, now in phase 3 for atopic dermatitis and phase 2 for asthma, and is also developing IL-33 inhibitor itepekimab in phase 3 for CRSwNP and COPD and phase 2 for chronic rhinosinusitis without nasal polyps.
Sanofi's head of R&D, Houman Ashrafian, called the AIRCULES and DUET results "promising" and said the data supports their "belief that the dual-targeting mechanism of lunsekimig may offer a novel treatment option for patients living with respiratory diseases, including asthma."
In AIRCULES, lunsekimig achieved a statistically significant reduction in asthma exacerbations and improvement in lung function, while in DUET it improved nasal polyp scores from baseline and improved symptoms such as nasal congestion and obstruction.
VELVET did not meet its primary endpoint of percentage change from baseline in eczema area severity index (EASI) score, but did meet some secondary objectives, including an increase in the proportion of patients reaching a 75% or greater improvement in the EASI total score compared to placebo.
Sanofi said lunsekimig was "generally well tolerated" in the studies. The drug was one of 12 identified by the drugmaker in 2023 as having the potential to contribute more than $1 billion in annual sales.
