Roche autoimmune disease drug disappoints in closely watched trial

2024-03-21

临床结果财报

An autoimmune disease drug from Roche and Chugai Pharmaceutical hit its main goal in a closely watched trial, but the results of the study, in a condition called myasthenia gravis, “did not reach our expectations,” the companies said Thursday.

Roche and Chugai have already brought the drug, known as Enspryng, to market for the rare eye condition neuromyelitis optica spectrum disorder. But the companies are working to expand its use elsewhere, including in myasthenia gravis, an autoimmune condition characterized by muscle weakness.

In recent years, myasthenia gravis has become a competitive area among drugmakers. AstraZeneca’s Soliris and Ultomiris are among the medicines available. More recently, Argenx’s Vyvgart became the first of a newer group of so-called FcRn inhibitors to get to market and has gotten off to a strong launch. Johnson & Johnson and Immunovant are advancing FcRn blockers as well.

Those drugs, though, faced a potential competitive threat from Enspryng. Recently published study results showed that tocilizumab, a drug that works similarly to Enspryng, might be an effective treatment for myasthenia gravis. That, in turn, had stoked fear among investors that the Enspyring trial could establish medicines like it, IL-6 inhibitors IL-6 inhibitors, as a “new standard-of-care” with “differentiated efficacy” and less frequent dosing than FcRn drugs, wrote Leerink Partners analyst Thomas Smith, in a note to clients Thursday.

The study tested Enspyrng in a trial that randomized 185 patients to receive the drug or a placebo over 24 weeks. The main goal was to outperform a placebo on a 24-point questionnaire.

Chugai revealed Thursday that Enspyring fell short of expectations on the “degree of clinical benefit” in the trial. The company didn’t provide further details, saving them instead for a medical meeting next month. It’ll continue developing Enspryng for other rare inflammatory conditions, such as thyroid eye disease and autoimmune encephalitis.

In the meantime, the effects of the findings rippled across to other developers. Argenx shared climbed 12% in Thursday morning trading, while Immunovant’s stock initially surged double digits before settling in to a smaller gain. Shares of Tourmaline Bio, which is developing an IL-6 drug for myasthenia gravis, fell nearly 40%.