• CORAT Therapeutics initiated a Phase Ib/II clinical trial evaluating the safety, tolerability, and efficacy of COR-101 in a total of 45 patients at five sites in Germany
Braunschweig, April 22, 2021. CORAT Therapeutics GmbH announced the start of a clinical trial with COR-101 for treatment of COVID-19 in hospitalized patients. The novel therapeutic antibody may complement currently approved antibody drugs, which are not indicated for moderate to severe COVID-19 cases due to side effects during advanced stages of the disease. Yesterday, the first patient was treated at the University Hospital of Tuebingen under the direction of Prof. Dr. Helmut Salih, Medical Director of the Clinical Cooperation Unit (KKE) Translational Immunology and national coordinating investigator of the clinical trial.
Currently approved vaccines protect people from acquiring COVID-19, but they are not effective in treating people with active COVID-19 disease. Also, not everyone responds to a vaccination. CORAT Therapeutics GmbH (CORAT) has developed a therapeutic antibody candidate specifically tailored for patients with moderate to severe COVID-19 disease – called COR 101. This candidate is now under clinical evaluation. The phase Ib/II trial (ClinicalTrials.gov ID: NCT04674566), which is being conducted at five study centers in Germany, is designed to evaluate the safety and tolerability, as well as the efficacy of COR-101 in hospitalized patients. Overall medical responsibility for the study lies with Prof. Dr. Helmut Salih at the University Hospital in Tuebingen, who treated the first patient of the study yesterday. Dr. Salih explains, "COR-101 is conceptualized to treat adult patients, who are hospitalized due to COVID-19 and who may already require oxygen. We are confident that this trial will produce successful outcomes for patients." Results from the first phase of testing are expected in a few months.
COR-101 is a fully human IgG monoclonal antibody isolated from recovered COVID-19 patients and developed under an accelerated process in consultation with regulatory authorities in record time. COR-101 prevents SARS-CoV-2 from infecting new cells by binding the surface of the virus thereby preventing that the virus attaches to human cells. In this context, Dr. Andreas Herrmann, CEO of CORAT emphasizes the difference of the mechanism of action compared to other antibody-based treatments, "In contrast to plasma therapy and some of the other emergency approved monoclonal antibodies, COR-101 is specifically designed not to induce elevated immune responses that contribute to lung damage. We have achieved this by knocking out the appropriate signaling sites in the molecule. This enables treatment of patients with high viral loads who already have advanced COVID-19 disease."
Andreas Herrmann comments, "We are very happy to have reached this step. Our special thanks go to Prof. Salih and his team, in particular Dr. Heitmann, for their excellent support in the design and implementation of the study, but also to our financial supporters, especially the state of Lower Saxony and our private investors. We are confident that COR-101 can fill the gap in medical need for the treatment of hospitalized COVID-19 patients with moderate and severe symptoms, for which no specific treatment is currently available worldwide. The development of specific agents, along with immunization and testing, is an indispensable pillar in the fight against the pandemic."