Sanofi chalks up another win for its immune system research

2023-06-27

临床结果并购上市批准免疫疗法临床研究

An experimental drug that Sanofi paid more than a billion dollars to acquire has scored positive results in a mid-stage study evaluating it as a treatment for moderate-to-severe eczema.

The study tested four doses of the injectable drug and, according to Sanofi, each was significantly better than a placebo at reducing the severity of patients’ disease. The company said there were other positive findings, too, including that participants on its drug had continued to improve 24 weeks into treatment.

The mid-stage clinical trial enrolled nearly 400 participants for whom topical eczema medications either haven’t worked or aren’t recommended. Sanofi said its drug, called amlitelimab, was generally well-tolerated across the various doses, with no new safety concerns identified. More detailed data will be presented at a future scientific meeting.

“While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options,” Naimish Patel, Sanofi’s head of global development for immunology and inflammation drugs, said in a statement. He added that the company plans to advance amlitelimab into late-stage testing, furthering its efforts to “drive momentum in our immunology pipeline to deliver first or best-in-class treatments.”

Sanofi got ahold of amlitelimab through the purchase of Kymab Kymab, a U.K.-based biotechnology company, in 2021. The deal carried an initial payment of $1.1 billion but offered up to $350 million more provided certain milestones were achieved.

The Kymab Kymab acquisition was one part of a larger push from Sanofi to become a more prominent developer of immune system drugs. The year before, it had agreed to acquire Principia Biopharma for $100 a share — reflecting a total deal value of $3.7 billion — for access to two experimental therapies that were already in mid- to late-stage human testing as treatments for multiple sclerosis and a rare autoimmune disease.

The investments continued into this year, with Sanofi buying Provention Bio for almost $3 billion. Provention’s Tzield, a medicine meant to delay the onset Type 1 diabetes, recently secured approval from the Food and Drug Administration. While Type 2 diabetes is typically considered a metabolic disorder, Sanofi management has said it considers Type 1 “closer to immunology.”

Amid this dealmaking, Sanofi has also had a string of clinical trial successes. Late last month, it said a drug it licensed six years ago from a biotech called ImmuNext had met the main goal of a mid-stage study of multiple sclerosis patients. And just a week or so earlier, the company reported that two trials testing itepekimab — a therapy it’s co-developing alongside Regeneron Pharmaceutical — had generated positive interim results in COPD, or chronic obtrusive pulmonary disease.

Sanofi and Regeneron’s marketed anti-inflammatory medication Dupixent has also shown promise in COPD, notching a victory in a late-stage study earlier this year.

To David Risinger, an analyst at the investment firm SVB Securities, the new amlitelimab results should help cast an even more favorable light on Sanofi’s immunology work.

Risinger wrote in a note to clients Tuesday that he and his team are “encouraged” that all four of the drug doses showed significant improvements compared to placebo. He also noted how amlitelimab’s dosing schedule of every four weeks could differentiate it from Dupixent, which was approved for eczema treatment in 2017 and is often administered once every two weeks.

Unlike Dupixent, amlitelimab is designed to inhibit a molecule that regulates certain immune cells thought to play a role in eczema. Amgen is developing a drug, rocatinlimab, that works similarly to Sanofi’s, and near the end of last year kicked off a late-stage study of it in moderate-to-severe eczema. The study aims to enroll about 680 participants and produce initial results next summer, according to a federal database.