New Data Released on Spesolimab Treatment for GPP

The New England Journal of Medicine recently published new data from the phase 2 Effisayil 1 study(NCT03782792) demonstrating that spesolimab (BI655130; Boehringer Ingelheim)significantly improved signs and symptoms of generalized pustular psoriasis (GPP) in patients experiencing a flare.¹

Spesolimab is a humanized monoclonal antibody that targets interleukin (IL)-36. The 12-week trial included 53 patients who were experiencing a GPP flare andthen treated with a single intravenous dose of spesolimab or placebo. The press release announcing the data stated that most patients at the outset of the trial had a high or very high density of pustules and impaired quality of life (QoL). After 1 week it was shown that:

• 54% of patients treated with spesolimab showed no visible pustules, compared to 6% of those treated with placebo.
• 43% of patients treated with spesolimab showed clear/almost clear skin, compared to 11% of those in the placebo group.

Some patients achieved pustular and skin clearance during the length of the study. Additionally, QoL improvements and symptoms like pain or fatigue were associated with clearance.

After the first week of treatment, spesolimab was associated with a higher number of infections and systemic drug reactions compared to placebo. There were 66% of patients treated with spesolimab experienced adverse events (AEs) compared to 56% of those treated with placebo after week 1. Likewise, infections were reported by 17% and 6% of patients in the spesolimab and placebo groups, respectively.

Serious AEs were reported in 6% of patients treated with spesolimab. Of that number, 2 patients reported drug reactions with eosinophilia and systemic symptoms.

“With no approved treatments in the US for GPP flares, there is a significant unmet need for people with this distressing and painful skin condition, which often requires emergency care," said Mark Lebwohl, MD, lead investigator and publication author, and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology, New York, New York. "These clinical trial results show that spesolimab has the potential to clear the skin of the signs and symptoms of a GPP flare after only 1 week, with effects observed through the end of the study."

The FDA has accepted a Biologics License Application (BLA) and granted priority review for spesolimab for the treatment of GPP flares. The FDA also granted spesolimaborphan drug designation for the treatment of GPP and breakthrough therapy designation for the treatment of GPP flares in adults.

"At Boehringer Ingelheim, we are committed to finding transformative therapies to help advance treatment for people who urgently need them," said Matt Frankel, MD, vice president, clinical development and medical affairs-specialty care, Boehringer Ingelheim, Ridgefield, Connecticut. "The findings indicate that spesolimab may have a significant and positive impact on the wellbeing of patients experiencing a GPP flare."

The program also includes the Effisayil 2 study (NCT04399837), assessing the safety and efficacy of spesolimab for the treatment of GPP, including flare prevention and symptom control over 48 weeks, and Effisayil ON,a 5 year, open-label extension study that will provide long-term efficacy and safety data for spesolimab in the treatment of GPP.

Reference:

1. Newly published results showed Spesolimab significantly improved signs and symptoms of flares in rare, life-threatening skin disease, generalized pustular psoriasis. Cision PR Newswire. Press Release. Published December 23, 2021. Accessed January 3, 2022. https://www.prnewswire.com/news-releases/newly-published-results-showed-spesolimab-significantly-improved-signs-and-symptoms-of-flares-in-rare-life-threatening-skin-disease-generalized-pustular-psoriasis-301449928.html