The purpose of our melflufen clinical development program is to support regulatory approval processes globally and explore safe and effective use in different patient populations, use in combination with other myeloma treatments and administration with both central and peripheral infusion, and real-world use in Germany and Spain.
Effective July 8, 2021, the U.S. Food and Drug Administration, FDA, requested a partial clinical hold of the clinical program with melflufen and OPD5 in the US, prompting Oncopeptides to refocus its clinical program to support the marketing authorization process in Europe that led to the approval of melflufen by the European Medicines Agency, EMA, and UK’s Medicines and Healthcare products Regulatory Agency, MHRA, in Aug and Nov 2022 respectively.
Clinical Development
The clinical development of targeted therapies for difficult-to-treat hematological diseases and malignancies has currently been done with our first peptide-drug candidate, melflufen. The PDC platform includes two additional compounds that are ready for clinical testing, and the SPiKE platform is aiming to initiate toxicology studies 2024 to enable clinical testing.
The purpose of our melflufen clinical development program is to support regulatory approval processes globally and explore safe and effective use in different patient populations, use in combination with other myeloma treatments and administration with both central and peripheral infusion, and real-world use in Germany.
New clinical studies may include additional non-interventional studies to explore real-life use in the market, or practice informing phase 4 studies in niche populations. Investigator initiated trials can also be practice informing and proposals are welcome and continuously reviewed for support.
Oncopeptides is currently re-starting clinical studies with melflufen, first one out being a non-interventional real-world study in Germany, called HARBOUR.
The second study is LAGOON, a non-interventional real-world study (NIS) in Spain.
