US-based biotechnology company Anaptys has reported positive topline results from the Phase III clinical trial of imsidolimab (IL-36R) to treat generalised pustular psoriasis (GPP).

The randomised, double-blind, placebo-controlled trial assessed the efficacy and safety of imsidolimab in GPP patients in the US, EU, Middle East and North Africa (MENA) and Asia. The Generalised Pustular Psoriasis Physician Global Assessment (GPPPGA) was used as the trial’s primary assessment, evaluating disease severity such as pustulation, erythema and scaling.

Study data from 45 patients treated with a 750mg dose of imsidolimab showed that over 50% scored 0/1 (clear or almost clear) on the GPPPGA, meeting the primary endpoint. This is compared to 13.3% of patients on the placebo.

Forty-two patients were enrolled in the GEMINI-2 trial. In the ongoing trial, patients are receiving monthly doses of 200mg subcutaneous insidolimab for three years to assess the efficacy and safety of the drug to prevent and reduce recurrent GPP flare-ups. Its topline data is expected in H2 2024.

Anaptys anticipate the filing of a biologics licence application (BLA) with the US Food and Drug Administration (FDA) towards the end of 2024, however the company has no plans to keep the drug.

Anaptys’ CEO Daniel Faga said: “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.”

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By GlobalData

This decision comes after imsidolimab failed in three different clinical trials across the past two years. One was a Phase II trial conducted in March 2021 for the treatment of palmoplantar pustulosis which did not meet its primary endpoint, scrapping further clinical development. In March and August 2022, imsidolimab did not show efficacy over placebo in either primary or secondary endpoints for its Phase II trial for the treatment of acne or hidradenitis suppurativa.

The California-based company has partnered with GSK to develop product candiates Jemperli (dostarlimab), cobolimab and GSK4074386.

Anaptys reported collaboration revenues of $10.3m at the end of 2022, a decrease of 83.7% compared to 2021, where the revenue was $63.2m, according to its  Q4 2022 financial results.