Sosei Group Corporation announced it has regained full ownership from GSK of HTL0027477 (formerly GSK4381406), a clinic-ready, highly selective, first-in-class, oral GPR35 agonist in development as a potential new treatment for Inflammatory Bowel Diseases (IBD). GPR35 is an important orphan G protein-coupled receptor ("GPCR") with an established genetic association to IBD, for which there remains significant unmet need for millions of sufferers worldwide. HTL0027477 was designed by Sosei Heptares using its proprietary structure-based drug design (SBDD) platform and licensed to GSK in 2020.

Since then, HTL0027477 has been advanced through a joint development program, generating promising mechanistic, preclinical efficacy and safety data suggesting that it may have the potential to improve intestinal barrier function and reduce visceral pain in gastrointestinal indications such as ulcerative colitis and irritable bowel syndrome. The UK Medicines and Healthcare products Regulatory Agency ("MHRA") gave approval in mid-2023 for HTL0027477 to be investigated in first-in-human studies. The process to regain rights to the program was initiated in late 2023 following a decision by GSK to prioritize and discontinue its development following changes to both its immunology research strategy and immunology research leadership.

The decision was not based on any scientific, preclinical or safety data related to the candidate. Sosei Heptares regained full ownership of the HTL0027477 program including associated intellectual property licensed by Sosei Heptare to GSK, and preclinical data generated under the partnership for no upfront payment. Sosei Heptares expects to determine the optimal strategy for further clinical development of the program, which could include in-house development and re-partnering.