Amplio Pharma receives EMA approval for Phase 1b trial in patients with rheumatoid arthritis
Amplio Pharma B.V. and its lead investors Libertatis Ergo Holding (LEH) and Amsterdam UMC Ventures Holding (AUMC-VH) are pleased to announce that Amplio Pharma has received the approval from the European Medical Agencey (EMA) to execute a Phase 1b clinical trial of its candidate drug product NovoBioJect. The study will be performed at the Leiden Centre for Human Drug Research (CHDR) in collaboration with the Amsterdam UMC Clinical Chemistry group led by Prof. Robert de Jonge. CHDR will recruit patients with rheumatoid arthritis who use methotrexate to treat this chronic disease. The objective is to examine the potential of the PK enhancer novobiocin on the efficacy/safety balance of this standard-of-care treatment.
NovoBioJect has the potential to significantly improve the global pharmaceutical care of patients with autoimmune diseases. In this novel drug product, the PK enhancer novobiocin is added with the objective to lead to a faster onset of disease remission in a larger patient population. A successful NovoBioJect not only translates into a decreased disease burden. It also comes with the potential to save billions of euro’s on an annual basis, supporting a more sustainable healthcare system throughout.
Amplio Pharma CEO Marguerite Mensonides stated : ”Our close collaboration with Amsterdam UMC, Leiden UMC, CHDR and OctoRelease have made it possible to reach this first milestone on our clinical journey with NovoBioJect. We look forward to reaching the next ones in the coming months.”
LEH managing director Rob Mayfield stated: “We’re very excited for this Phase 1b study to start and pleased that our support has been instrumental to getting to this milestone. We look forward to seeing the first interim results later this year.”
AUMC-VH managing director Rudi Rust stated “The EMA’s approval to start this Phase 1b trial marks an important milestone for Amplio Pharma and its partners, bringing us a step closer to improving treatment options for patients with rheumatoid arthritis.”
Read other articles
