Sanofi’s mlitelimab met all endpoints in COAST 1 Phase 3

Sanofi’s mlitelimab met all endpoints in COAST 1 Phase 3

Sanofi has announced that its investigational drug amlitelimab has met all primary and secondary endpoints in the COAST 1 Phase 3 trial. The trial, designed to evaluate the efficacy and safety of amlitelimab in treating moderate-to-severe atopic dermatitis (AD), showed significant improvements in the disease's symptoms and quality of life for patients [1].

The COAST 1 trial enrolled 484 patients and compared amlitelimab with a placebo. The primary endpoint was the percentage of patients achieving a 75% reduction in the Eczema Area and Severity Index (EASI) score at week 16. Amlitelimab demonstrated a statistically significant improvement in this metric, with 39.6% of patients in the treatment group achieving a 75% reduction, compared to 15.8% in the placebo group [2].

The secondary endpoints, which included the percentage of patients achieving a 50% reduction in EASI score and the Investigator's Global Assessment (IGA) score, also showed significant improvements. Amlitelimab showed a 47.1% reduction in EASI score and an IGA score improvement of 2.1 points, compared to 20.3% and 0.6 points for the placebo, respectively [2].

The safety profile of amlitelimab was consistent with previous studies, with no new safety concerns identified. The most common adverse events were mild to moderate in nature and included injection site reactions, upper respiratory tract infections, and nasopharyngitis [2].

The successful results of the COAST 1 trial have led Deutsche Bank to upgrade its recommendation for Sanofi shares from "hold" to "buy." The analysts at Deutsche Bank have cited the potential of amlitelimab to replace Dupixent, Sanofi's flagship drug, which accounts for nearly half of its pharmaceutical revenues [3]. The patent for Dupixent is set to expire in 2031, creating a significant risk for the company's stock market valuation. However, the upcoming Phase 3 results for amlitelimab could significantly boost the company's revenues and mitigate this risk.

The upcoming Phase 3 results for amlitelimab will be closely watched by investors, as they could significantly impact Sanofi's future prospects. The company's ability to diversify its revenue streams and mitigate the risks associated with the expiration of its flagship drug's patent will be crucial for its long-term success.

References:
[1] https://www.webwire.com/ViewPressRel.asp?aId=343325
[2] https://www.ainvest.com/news/sanofi-deutsche-bank-upgrades-buy-recommendation-hold-hold-2509/