Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, today announced that the first patient was dosed in a Phase I trial of SCB-808, a proposed biosimilar of Enbrel (etanercept) being developed in the prefilled syringe formulation for the treatment of rheumatoid arthritis and other autoimmune diseases.
“This milestone marks Clover’s second biologic product to initiate human clinical trials in as many months. Now with clinical trials actively enrolling patients in multiple countries, Clover has demonstrated its ability to execute on its goals across multiple functional areas,” said Joshua Liang, Chief Strategy Officer and Board Director at Clover. “We look forward to further advancing our deep pipeline of promising biological candidates in the months ahead.”
The Phase I trial in China is designed to assess the pharmacokinetics, safety and immunogenicity of subcutaneously administered SCB-808 and originator drug Enbrel in healthy volunteers.
“Having compared SCB-808 to both Enbrel and other Chinese etanercept biosimilars in preclinical studies, we believe that our superior biomanufacturing process, biosimilarity to Enbrel and convenient ready-for-injection prefilled syringe formulation will allow us to have significant commercial advantages once SCB-808 is brought to the market,” said Dr. Peng Liang, co-founder, Chairman and President of Clover. “Importantly, we hope that SCB-808 will meaningfully impact the lives of many patients, and the initiation of this Phase I trial brings us one step closer to this goal.”
Currently available etanercept biosimilars in China were all developed and approved prior to the implementation of the CFDA’s Technical Guideline for Development and Evaluation of Biosimilars and were not compared to the originator drug Enbrel in clinical trials to demonstrate their bioequivalence. Furthermore, they are only approved in the lyophilized powder formulation, which must be reconstituted typically by trained medical personnel before being subcutaneously injected into patients. SCB-808 is being developed in the prefilled syringe formulation, which is ready-for-injection and can potentially be self-administered by patients in the convenience of their own homes. Thus, in the Western world, ready-for-injection formulations constitute the overwhelming majority of Enbrel prescriptions. As such, Clover’s SCB-808 has the potential to address the unmet needs of Chinese patients for this class of drugs.
In addition SCB-808, Clover has two additional undisclosed biosimilars in development and six other candidates in development.