Sosei has announced that the first healthy subject has been dosed in a Phase I study of HTL0030310, a selective SSTR5 (somatostatin 5) receptor agonist in development to treat endocrine disorders.
The dosing marks the start of a new in-house clinical programme targeting endocrine disorders, including Cushing’s disease with HTL0030310, which has been designed to modulate the excess release of hormones from adenomas (benign tumours) of the pituitary gland.
The drug is a potent and selective agonist of the SSTR5 receptor and the sixth molecule to be designed by the company using its GPCR Structure-Based Drug Design (SBDD) platform to enter clinical development.
Highly elevated plasma levels of pituitary hormones result in a number of serious endocrine disorders, including Cushing’s Disease, which is characterised by excessive cortisol release, crucial in regulating metabolism, maintaining cardiovascular function and helping the body respond to stress.
Dr Malcolm Weir, executive VP and chief R&D officer, said: “We are not only pleased to begin this new study but also delighted with the productivity of our unique platform to generate attractive candidates targeting GPCRs involved in multiple diseases.
"These candidates present new prospects for our emerging proprietary pipeline, as well as unique opportunities for partnering, and provide a solid foundation to execute our strategy.”
Preliminary results from the trial are expected in the second half of 2019 and will provide a first insight into the effects of HTL0030310 on the control of glucose and other endocrine hormones and the potential to target Cushing’s disease and other endocrine disorders.