Dive Brief:
- An experimental, dual-acting drug from Sanofi succeeded in two studies in different respiratory conditions but missed its mark in an eczema trial, the French drugmaker said Tuesday.
- Known as lunsekimig, the therapy met its main and key secondary goals in Phase 2 studies evaluating the treatment in moderate-to-severe asthma and chronic rhinitis with nasal polyps. In asthma, treatment led to a “statistically significant and clinically meaningful” reduction in symptom flare-ups and helped improve lung function. Lunsekimig reduced the size and severity of nasal polyps, as well as related congestion, in the other trial, Sanofi said.
- Lunsekimig didn’t meet its main objective in a separate trial in atopic dermatitis, failing to meet a certain threshold of skin clearance compared to a placebo. The drug was “generally well tolerated” across the trials, with serious adverse events and discontinuation rates comparable between treatment and placebo recipients. Two Phase 3 trials are underway in chronic obstructive pulmonary disease, another lung condition.
Dive Insight:
Sanofi is under growing pressure to find a successor to Dupixent, a top-selling drug for an array of immunological conditions. Co-developed with Regeneron, the treatment accounted for about a third of Sanofi’s sales last year and could lose patent protection in the U.S. in 2031.
Yet finding a new biologic that can stand out in an increasingly crowded field is proving difficult. One therapy Sanofi has put considerable resources into, amlitelimab, hasn’t been as effective or safe in testing as investors had hoped, leading analysts to significantly pare down financial projections. Now Sanofi has delivered mixed results with lunsekimig, a bispecific drug that targets two known drivers of inflammation, TSLP and IL-13.
Ahead of the results, R&D chief Houman Ashrafian noted that biologics for asthma were increasingly producing similar effects on symptom flare-ups, suggesting “the field may be nearing a biological ceiling,” Leerink Partners analyst David Risinger wrote in a Tuesday note.
Sanofi, then, has been looking to prove that lunsekimig might differentiate in other ways, such as through a bigger impact on lung function and overall disease control. Risinger noted how, ahead of the results, the company had been hoping lunsekimig would prove “competitive” on flare-ups while separating itself “where unmet need remains greatest.”
Sanofi didn’t provide detailed results Tuesday, leaving the drug’s competitive standing unclear. They’ll be presented at a future medical meeting. But it did note in a statement that the treatment benefits observed in asthma were seen “regardless of biomarker status.” That finding suggests the treatment and the technology it’s based on — which Sanofi acquired from biotechnology company Ablynx — “may have broader potential,” wrote Jefferies analyst Michael Leuchten.
Leuchten is forecasting $3 billion in peak yearly sales for lunsekimig based on its positioning in respiratory diseases alone. Expectations in eczema were low given the “limited evidence” of a synergistic effect between TSLP and IL-13 inhibition, Risinger wrote.
