Vanda Pharmaceuticals secures global rights to develop and market Imsidolimab, an IL-36R antagonist, through agreement with Anaptys
Tuesday, February 04, 2025
Vanda Pharmaceuticals and AnaptysBio have signed an exclusive global agreement for the development and commercialisation of imsidolimab, an IL-36R antagonist monoclonal antibody. The treatment has completed two Phase 3 trials, GEMINI-1 and GEMINI-2, assessing its safety and effectiveness for Generalised Pustular Psoriasis (GPP).
GPP is a rare skin condition linked to mutations in the IL36RN gene, which regulates inflammatory IL-36 cytokines. Disruptions in IL-36 signalling can cause severe skin inflammation, pustules, and systemic complications that may lead to serious health risks. Imsidolimab works by inhibiting IL-36R function, compensating for the deficiency of the natural IL-36 regulator in GPP patients.
Following the completion of the Phase 3 studies, Vanda plans to finalise technology transfer activities in 2025 and begin preparations for regulatory submissions in the US and EU, along with commercial launch planning.
GPP affects between 1.76 and 124 people per million worldwide, with most cases linked to genetic variations in IL36RN. Loss-of-function mutations in this gene lead to uncontrolled IL-36 activity, which contributes to disease progression.
Under the agreement, Vanda will pay Anaptys an initial $10 million, along with an additional $5 million for existing drug supply. Anaptys may receive up to $35 million in future regulatory and sales milestone payments, as well as a 10% royalty on net sales. Vanda gains exclusive global rights to develop, manufacture, and commercialise imsidolimab.
Clinical trial results from GEMINI-1 showed that 53% of patients who received a single 750mg intravenous (IV) dose of imsidolimab achieved clear or almost clear skin at Week 4, compared to 13% of those on placebo. Similar results were seen in patients receiving a 300mg IV dose. The GEMINI-2 trial assessed long-term maintenance therapy, with 100% of patients on a monthly 200mg subcutaneous (SC) dose maintaining clear or almost clear skin, while 63% of those on placebo experienced a disease flare.
The studies confirmed that imsidolimab had a consistent safety and tolerability profile, with no treatment-related serious adverse events reported.
Source: prnewswire.com
