PEP-Therapy announced that the FDA has granted Orphan Drug designation to its flagship product, PEP-010, for the treatment of pancreatic cancer.
PEP-010, PEP-Therapy’s first-in-class bifunctional therapeutic peptide is being studied in an ongoing Phase Ib clinical trial evaluating safety, tolerability, pharmacokinetics and preliminary anti-tumor activity, in combination with chemotherapy (paclitaxel or gemcitabine), in particular in patients with pancreatic cancer.
“Obtaining Orphan Drug Designation for PEP-010 marks a significant milestone in our efforts to develop our drug candidate for pancreatic cancer and highlights the significant unmet medical need that exists for these patients” said Hatem Azim, MD, PhD, Chief Medical Officer of PEP-Therapy. “They currently have limited treatment options, and the growing incidence and mortality of pancreatic cancer underscores the urgency for new therapies. ODD along with encouraging initial data from our ongoing Phase I study strengthen the advancement of PEP-010 as a potential novel alternative."
Antoine Prestat, CEO and co-founder of PEP-Therapy, added: "Receiving FDA’s ODD is an important milestone for PEP-Therapy. It will support our objective to accelerate the development of PEP-010 toward delivering an innovative solution for challenging-to-treat cancers. We look forward to reporting updated clinical data.”
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