India Pharma Outlook Team | Tuesday, 04 February 2025
Vanda Pharmaceuticals Inc. and AnaptysBio, Inc. revealed an exclusive worldwide licensing agreement for the development and marketing of imsidolimab (IL-36R antagonist mAb), which has successfully finished two registration-supporting global Phase 3 trials, GEMINI-1 and GEMINI-2, assessing the safety and effectiveness of imsidolimab in patients diagnosed with Generalized Pustular Psoriasis (GPP).
GPP is an uncommon skin condition typically resulting from mutations in the IL36RN gene, which encodes a regulatory protein that moderates the function of the proinflammatory IL-36 family of cytokines. Disruption of this balance in IL-36 signaling results in intense chronic skin inflammation characterized by pustules and systemic symptoms, contributing to considerable morbidity and mortality frequently linked to sepsis and multi-organ failure.1
Imsidolimab blocks the activity of IL-36R, compensating for the lack of the natural IL-36 regulator in individuals suffering from GPP. Imsidolimab has effectively completed its development program in GPP, which encompasses the GEMINI-1 and GEMINI-2 global Phase 3 trials.
"We are excited to add imsidolimab to Vanda's product portfolio for rare orphan disorders, as well as explore the potential of this IL-36 signal regulator in the treatment of additional inflammatory conditions where the IL-36 homeostatic balance is dysregulated," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Imsidolimab has great synergy with our commercial portfolio, leveraging both our rare disease expertise in the US and EU as well as the anti-inflammatory portfolio that includes Ponvory® for multiple sclerosis, psoriasis and ulcerative colitis."
, CDSCO.jpg)
