Syntara Limited (ASX: SNT), a clinical-stage drug development company, today announces that the World Health Organization (WHO) has formally granted the International Non-Proprietary Name (INN) of amsulostat to its advanced clinical development asset SNT-5505.
Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient.
Amsulostat is an innovative oral therapy currently in clinical development for myelofibrosis (MF), a debilitating bone marrow disorder characterised by fibrosis that severely impacts blood cell production.
Recent interim Phase 2 clinical trial results, which demonstrated promising efficacy and an excellent safety profile in combination with ruxolitinib, underscore the potential of amsulostat as a differentiated treatment option for patients with MF who exhibit suboptimal responses to existing therapies.
The designation of an INN represents an important milestone in the drug development process, providing global recognition of amsulostat’s unique chemical identity and facilitating clearer communication among healthcare
professionals and regulatory bodies worldwide.
Syntara CEO Gary Phillips said: “After very recently being awarded Fast Track Designation by the FDA, the granting of amsulostat as the INN for SNT-5505 is another important step forward, reflecting the drug’s unique mechanism of action and clinical promise. We remain focused on advancing amsulostat through clinical development to address significant unmet medical needs in myelofibrosis and other fibrotic diseases.”
