Ribocure Pharmaceuticals AB receives Authorisation for a Phase II clinical trial to evaluate efficacy and safety of its novel siRNA asset for treatment of chronic hepatitis B infection.
Ribocure Pharmaceuticals AB, a pioneering Swedish biotech company and the international research center of Ribo Life Science Ltd, focused on development of cutting-edge RNA therapeutics, is delighted to announce that we have received Authorisation for a Phase II clinical trial to study efficacy and safety of RBD1016 in patients with chronic HBV infection through the newly launched European Union Clinical Trials Information System (CTIS). This Authorisation represents a significant milestone for the company as it marks our first Authorisation based on our proprietary siRNA platform within the EU and a crucial step forward in advancing our novel therapeutics towards the global market.
The Phase II study will assess efficacy and safety of our promising investigational drug RBD1016, a GalNAc-conjugated siRNA molecule based on our proprietary Ribo-GalSTARTM, targeting the X gene of hepatitis B virus. RBD1016 has already shown high potency and potential class-leading durability in a Ph1b study in target patient population. With this Ph2 study, we will further evaluate its potential for functional cure of this devastating disease still affecting millions of patients around the globe.
“We are thrilled to have received this Authorisation and one notable achievement in this process was the swift and efficient submission through CTIS system, within less than a month from the CTIS implementation date, the application was successfully submitted,” commented Prof Li-Ming Gan, CEO of Ribocure Pharmaceuticals and R&D President of Ribo Life Science Ltd.
“This momentous occasion is a testament to the dedication and expertise of our team. We are excited to embark on this journey and further validate the potential of our cutting-edge RNA therapeutics. We are deeply impressed by the high-quality feedback and the impressive speedy and efficient regulatory review process. I truly believe our advanced technology under guidance of this new world-leading regulatory process will make Sweden/EU a competitive place to be for bringing life-saving novel therapies to patients in need”.
