We thank the European Society of Cardiology #ESC Congress, session chairs, and all participants in the session for the opportunity and attention. We look forward to continuing the further clinical development of RBD4059 based on our Phase 1 results.
“We are excited to have progressed world’s first and most advanced FXI siRNA program, now into Phase2, based on these encouraging data from phase 1. The molecule fulfills the target product profile we set up to achieve in terms of clinically meaningful and relevant potency and duration, which clearly differentiates from all established anti-thrombotic therapies as well as profiles of all other FXI inhibition programs in clinical development, including small molecules and antibodies. Also, Ribo is extremely encouraged to see the low inter-individual variability in treatment response, which further strengthens the first- and best-in-class potential of the program” says Professor Li-ming Gan, CEO Ribocure Pharmaceuticals AB and co-CEO Suzhou Ribo Life Science, Ltd.
Results in short summarized below:
- RBD4059 demonstrated dose-dependent, predictable PK, and pronounced (>90%) and durable FXI activity and protein reduction in in the dose range of 50 mg – 600 mg.
- Primary endpoint for safety and tolerability has been met – RBD4059 demonstrated favorable safety profile with no identified adverse safety signals across the investigated dose-range.
- This first-in-human study supports the further development of RBD4059 as an anticoagulant that can maintain a high level of PD effect with every 3- or 6-months dosing regimen, with potential for enhanced compliance and low bleeding risk in chronic anti-coagulant therapy.
- A randomized, double-blind, placebo-controlled Phase IIa clinical trial to evaluate safety, pharmacokinetics, and pharmacodynamics of repeated subcutaneously administered RBD4059 in participants with stable coronary artery disease has been approved by EMA and the first patient was enrolled on the 28th of August 2024 in Ribocure Clinic based in Gothenburg, Sweden.
