Sosei Heptares, a biopharmaceutical company, is poised to reclaim full ownership of its promising drug candidate GSK43814061, intended for the treatment of inflammatory bowel disease (IBD). The decision comes after the original licensee, GlaxoSmithKline (NYSE:GSK), chose to return the rights due to an internal strategy shift.
The oral GPR35 agonist, GSK43814061, has shown potential in preclinical studies by improving intestinal barrier function and reducing gastrointestinal pain. These encouraging results led to the approval by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for human trials expected to commence by mid-2023.
Sosei Heptares had initially licensed the drug to GSK in 2020. Despite GSK's strategic realignment leading to the return of rights, the companies will maintain a low single-digit royalty agreement on future sales of the drug.
As Sosei Heptares prepares to manage early clinical trials in the UK independently, the company is also considering various development paths or partnerships for GSK43814061. This approach aligns with Sosei Heptares' strategy following its acquisition of Idorsia's pharmaceutical sectors in Japan and Korea, which has strengthened its presence in Japan/Asia-Pacific and bolstered its drug advancement capabilities.
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