As per Sosei Heptares, the 2020 agreement with GSK grants them the right to regain full ownership of the GSK4381406 programme and all associated intellectual properties at no upfront cost. Image Credit: fizkes / Shutterstock.

Sosei Group Corporation has initiated discussions to regain full ownership of the oral inflammatory bowel disease (IBD) drug GSK4381406 from GSK.

Sosei Heptares plans to regain ownership of GSK4381406 following GSK’s decision to “deprioritise and discontinue its development due to changes to both its immunology research strategy and immunology research leadership”, as per a 24 November press release.

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The company was quick to add that the programme discontinuation was not associated with any preclinical or safety data generated for GSK4381406.

GSK acquired global rights to Sosei Heptares’s digestive system disorder drug portfolio, including GSK4381406, in 2020. Sosei Heptares received up to £34m ($44m) in upfront costs, development milestones and research funding, as per a 21 December 2020 press release.  

As per the agreement, the companies were to collaborate on research and early preclinical development for the drug while GSK was to lead clinical development, manufacturing, and commercialisation.

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According to Sosei Heptares, the 2020 agreement grants them the right to regain full ownership of the GSK4381406 programme and all associated intellectual properties at no upfront cost. However, GSK would be entitled to single-digit royalties on net sales of the drug, if it becomes commercially available.

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GSK4381406 is a selective G protein-coupled receptor 35 (GPR35) agonist. It was developed by Sosei Heptares using its proprietary StaR technology and structure-based drug design platform.

GSK received clearance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to start the Phase I trial (NCT05999708). The three-part placebo-controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of GSK4381406. The study is expected to enrol 84 healthy volunteers, as per ClinicalTrials.gov.

Sosei Heptares plans to seek partnership for the development and commercialisation of GSK4381406. The company also plans to utilise its clinical development and commercialisation capabilities in the Japan and Asia Pacific regions, excluding China.

The company acquired the Asia Pacific operations from Idorsia in July. The deal also included global rights to Pivlaz (clazosentan) and regional licensing rights to daridorexant.

In October, Sosei Heptares expanded its drug discovery agreement with PharmEnable Therapeutics to include a second neurological disease target. The company is also developing a cancer immunotherapy drug in collaboration with Cancer Research UK. The drug is currently being evaluated for treating advanced solid tumours in a Phase I/IIa clinical trial (NCT05944237).