Sanofi’s TSLP and IL-13 inhibitor has aced a pair of mid-stage studies for respiratory diseases, but missed on a phase 2 eczema trial.
The asset, called lunsekimig, hit the primary endpoint of demonstrating a statistically significant reduction in exacerbations after 48 weeks in the phase 2b Aircules study of adults with moderate-to-severe asthma. The drug also achieved the key goal of reducing nasal growths called polyps over 24 weeks in the phase 2a Duet study of patients with chronic rhinosinusitis, a type of inflammation of the nasal cavity.
But lunsekimig proved less successful in the phase 2b Velvet study, which missed its primary mission of demonstrating a reduction in eczema severity among patients with moderate-to-severe atopic dermatitis, Sanofi said in an April 7 release. The drug did show improvements in secondary endpoints like skin clearance, the company noted.
Sanofi is holding back the data for upcoming medical congresses, but said lunsekimig was “generally well tolerated” across the trio of studies. The most common treatment-emergent adverse events (TEAEs) in the Aircules trial were nasopharyngitis, upper respiratory tract infection, headache, and dose scheduling errors, while for the Duet trial they were injection site reaction or erythema, viral upper respiratory tract infection, nasopharyngitis, nosebleed, ear pain, and increased creatine phosphokinase.
“Overall, rates of serious adverse events and TEAEs leading to treatment discontinuation in both studies were similar in the lunsekimig group and the placebo group,” the pharma explained.
When it came to the Velvet study, Sanofi only said that the drug was “generally well tolerated and had a safety profile consistent with the other studies.”
“These data are promising and support our belief that the dual-targeting mechanism of lunsekimig may offer a novel treatment option for patients living with respiratory diseases, including asthma,” Sanofi’s head of R&D Houman Ashrafian, Ph.D., said in the April 7 release.
“Importantly, these findings underscore lunsekimig’s potential to address multiple critical aspects of respiratory disease management through its unique mechanism,” Ashrafian added.
Lunsekimig is a bispecific Nanobody constructed of five linked antibody fragments designed to block thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), which are both drivers of inflammation that contribute to tissue damage in asthma and related diseases.
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This year has already seen a growing body of evidence of the potential for targeting TSLP to treat inflammatory diseases. Pfizer’s phase 2 atopic dermatitis win for its IL-4, IL-13 and TSLP-targeting tilrekimig followed a Tezspire-like reduction in asthma exacerbations seen by Upstream Bio’s TSLP antagonist. Meanwhile, Generate:Biomedicines was able to score a $400 million IPO to fund phase 3 asthma trials of its own anti-TSLP antibody.
For Sanofi, which announced its decision in February to oust its CEO following a year of clinical setbacks, this morning’s two phase 2 wins in respiratory disease are a timely validation of the company’s pipeline. But lunsekimig’s eczema failure means Sanofi is no closer to having a guaranteed successor to its blockbuster dermatitis drug Dupixent as the patent cliff approaches.
The pharma has already taken lunsekimig into a pair of phase 3 studies for chronic obstructive pulmonary disease and the drug is also undergoing a phase 2 study for high-risk asthma.
