US-based clinical-stage company Sterotherapeutics has announced the commencement of a Phase II clinical trial for its drug candidate, ST-002, for treating Cushing’s Syndrome, a rare endocrine disorder.
The trial will assess the drug’s efficacy, tolerability, and safety in individuals with this condition. It is set to be conducted in several European clinical sites.
Go deeper with GlobalData
Sterotherapeutics CEO Manohar Katakam said: “After extensive preparations and based on a large body of scientific data, we are excited to convene this important Investigator Meeting as we progress to the next stage of our clinical development programme.
“This trial represents a significant step forward in our mission to develop transformative therapies for unmet medical needs. Collaboration with our expert investigators is essential to ensuring the highest standards of scientific rigour and patient safety.”
An orphan drug designation was granted by the US Food and Drug Administration (FDA) to the drug underscoring the requirement for new treatments alternatives for this rare condition.
Through this designation, Sterotherapeutics is eligible for various development incentives. These include assistance in the drug development process, certain FDA fee exemptions, post-approval marketing exclusivity of seven years, and tax credits for clinical expenses.
Characterised by longer exposure to high cortisol levels, Cushing’s Syndrome is stated to result in serious health complications like diabetes, osteoporosis, and hypertension.
Sterotherapeutics concentrates on the orphan diseases therapy development. The company stated that its leading programmes, ST-002 for Cushing’s Syndrome and ST-003 for primary sclerosing cholangitis, have shown promise in prior animal and human studies. ST-003 has also been granted an orphan drug designation by the US regulator.
