Japan-based biopharmaceutical group Sosei Heptares has initiated the HTL0030310 clinical development programme for the treatment of endocrine disorders, including Cushing’s disease.

The company has already commenced dosing in a Phase I clinical trial.

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HTL0030310 is a small molecule, potent and selective agonist of the somatostatin 5 (SSTR5) receptor. It is developed using the company’s GPCR Structure-Based Drug Design (SBDD) platform.

The compound is designed to regulate the excess release of hormones from pituitary gland adenomas that could lead to a variety of serious endocrine disorders.

It is said to be significantly selective towards SSTR5 and is expected to enhance the balance of efficacy and dose-limiting side effects.

“HTL0030310 is a novel and highly selective molecule, and is the sixth candidate originating from our SBDD platform to advance into human trials.”

The double-blind, randomised, placebo-controlled Phase I trial will evaluate HTL0030310’s safety, tolerability, pharmacokinetics and pharmacodynamics.

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It will investigate single ascending subcutaneous doses of the product in a total of up to 64 healthy male and female participants.

With preliminary results anticipated in the second half of this year, the trial data will offer insights into the effect of HTL0030310 on the control of glucose and other endocrine hormones.

Sosei Heptares executive vice-president and chief R&D officer Malcolm Weir said: “HTL0030310 is a novel and highly selective molecule, and is the sixth candidate originating from our SBDD platform to advance into human trials.

“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.”

The company’s pipeline comprises multiple product candidates across different therapeutic areas such as immuno-oncology, gastroenterology, inflammation and central nervous system conditions.