AnaptysBio has unveiled promising phase 3 data for its rare skin disease drug candidate, indicating a potential challenge to Boehringer Ingelheim’s position in generalized pustular psoriasis (GPP). Anaptys, headquartered in San Diego, originally intended to bring imsidolimab to the US market independently. However, after imsidolimab’s phase 2 trial for hidradenitis suppurativa proved unsuccessful last year, the company shifted its strategy. While continuing the phase 3 GPP study, Anaptys decided to explore out-licensing the asset should it receive FDA approval.
The latest developments include the release of top-line data from the late-stage trial. The study involved 45 patients who received a single intravenous dose of anti-IL-36R antibody imsidolimab or a placebo. Remarkably, four weeks later, over half (53.3%) of the individuals administered imsidolimab achieved a clear or almost clear score on a physician assessment scale, significantly outperforming the placebo response rate of 13.3%. This achievement marked the successful attainment of the study’s primary endpoint.
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If imsidolimab secures approval, it will encounter a formidable rival in Boehringer Ingelheim’s Spevigo, an IL-36R drug that received FDA approval last year. Boehringer’s approval was based on a clinical trial assessing its impact on pustulation, one of the factors considered in the physician scale employed in Anaptys’ study. Boehringer demonstrated that one week after treatment, 54% of patients receiving Spevigo achieved a clear pustulation score, in contrast to a mere 6% of those in the placebo group.
Boehringer also assessed the overall physician scale as a secondary endpoint, revealing that one week after treatment, 43% of Spevigo-treated participants achieved clear or almost clear ratings, compared to just 11% in the placebo group. In an exploratory endpoint, Spevigo was associated with a remarkable 66% rate of clear or almost clear scores in Week 4.
“The success of the GEMINI-1 trial highlights Anaptys’ commitment to patients and our ability to internally discover and develop differentiated antibodies. Moving forward, we intend to out-license imsidolimab with this compelling and competitive dataset to bring this therapy to patients living with this highly morbid condition and reallocate the potential proceeds of a transaction to further invest in the broad development of our best-in-class immune cell modulators, including our checkpoint agonists, in autoimmune and inflammatory diseases.”
– Daniel Faga, president and chief executive officer of Anaptys
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“GPP is an unpredictable and potentially life-threatening skin disease with systemic symptoms. Achieving positive top-line results utilizing the GPPPGA composite endpoint in this well conducted, randomized controlled, global trial, along with a compelling safety profile, represents the potential for a single dose of imsidolimab to predictably provide relief for patients living with this burdensome disease.”
– Professor Hervé Bachelez, M.D., Ph.D., Hôpital Saint-Louis, Paris, one of the world’s leading experts on GPP.
AnaptysBio intends to file for FDA approval in the third quarter of 2024 and explore opportunities to out-license the drug candidate in the following year. Following the announcement, Anaptys’ shares briefly surged by 17% to $22.51 in premarket trading on Monday, eventually settling at $20.54. These developments signal a potential shake-up in the landscape of GPP treatments, with imsidolimab emerging as a compelling contender.
