Oscotec Inc, a clinical stage drug discovery and development company, announced on Thursday that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its SYK inhibitor, Cevidoplenib.
The product is intended for the treatment of immune thrombocytopenia (ITP).
The company successfully completed its phase two study of the product in subjects with chronic ITP last year, and is presently looking for partners for further development and global commercialisation.
Dr Taeyoung Yoon, CEO/CSO of Oscotec, said, 'Potential partners are drawing attention not only to the efficacy of cevidoplenib but also its exceptional safety profile and the convenience of oral dosing. Obtaining ODD is an important milestone in the development of cevidoplenib and ultimately will benefit patients. We will explore every available option including partnership to deliver our drug as quickly as we can to those who suffers from the potentially crippling disease.'
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