Boehringer Ingelheim touts prevention results in rarest form of psoriasis
Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.
Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.
“Painful GPP flares can occur suddenly, escalate quickly, and may require urgent hospital care leaving people anxious and uncertain about what the future might hold,” Carinne Brouillon, a member of the company’s board of managing directors responsible for the Human Pharma Business Unit, said in the news release. The company was not immediately available for comment.
GPP is the rarest form of psoriasis, and is characterized by red and inflamed patches of skin, as well as small pustules. The condition is sometimes mistaken for an infection, and until Spevigo’s approval back in September, there were no drugs officially approved to treat it. In serious cases, the condition can lead to heart failure, renal failure and sepsis.
While most patients enrolled in a Phase II pivotal trial had a “high or very high” density of pustules, 54% showed no visible pustules after a week of treatment with Spevigo, compared to 6% of those on a placebo, according to Boehringer.
The EFFISAYIL 2 trial showed a “significant prevention of generalized pustular psoriasis (GPP) flares for up to 48 weeks” in adolescents and adults, the company said on Monday.
AnaptysBio is developing its own IL-36R antibody, imsidolimab, for the same indication, though it said last year that it would look to out-license the candidate before a potential FDA approval. According to the company’s website, topline data are expected in the fourth quarter of this year.