COR-101 / Corat Therap, Dermapharm - LARVOL DELTA

Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19 (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Corat Therapeutics Gmbh | Trial completion date: Oct 2021 ➔ Oct 2022 | Trial primary completion date: Oct 2021 ➔ Oct 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Two more COVID-19 drugs are being tested in Ukraine (Ukraine News) - "The Ukrainian Ministry of Health has approved clinical trials of two drugs from COVID-19 . The application for the trials was submitted by China and Germany....The German drug COR -101 is also being tested. This is a phase 2 parallel group study in which the drug will be used in humans for the first time. In this case, the safety, tolerability, pharmacokinetics, pharmacodynamics and effectiveness of the drug are examined."

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19 (clinicaltrials.gov) - P1/2; N=45; Recruiting; Sponsor: Corat Therapeutics Gmbh; Trial completion date: Jun 2021 ➔ Oct 2021; Trial primary completion date: Jun 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A SARS-CoV-2 neutralizing antibody selected from COVID-19 patients binds to the ACE2-RBD interface and is tolerant to most known RBD mutations. (PubMed, Cell Rep) - "The binding and inhibition of STE90-C11 is not blocked by many known emerging RBD mutations. STE90-C11-derived human IgG1 with FcγR-silenced Fc (COR-101) is undergoing Phase Ib/II clinical trials for the treatment of moderate to severe COVID-19."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

COR-101 also inhibits the rapidly spreading "Indian" variants of SARS-CoV-2 including "Delta" [Google translation] (IDW News) - "Here the COR-101 antibody shows the best activity in neutralizing the viruses.The efficiency of the antibody was confirmed in transgenic mice carrying the human ACE2 receptor and in hamsters. The viruses could be efficiently reduced or completely eliminated. The structure of the antibody and its binding to the receptor binding site was clarified at the atomic level and shows that the antibody directly blocks the virus from docking on the cells. COR-101 also binds and inhibits the spike protein of the newly emerging 'Indian' SARS-CoV-2 variants (B.1.617.1 and .3)....Even the new dangerous 'Indian' variant B.1.617.2 (Delta) is efficiently inhibited."

Preclinical • Infectious Disease • Novel Coronavirus Disease

CORAT Therapeutics GmbH announces partnership with Dermapharm Holding SE as strong strategic partner for the further development of COR-101 (PRNewswire) - "...CORAT Therapeutics GmbH announces the partnership with Dermapharm Holding SE, a manufacturer of branded pharmaceuticals. The partnership is intended to accelerate clinical development and facilitate the expansion of COR-101 production to make the drug available to patients more quickly....Currently, the neutralizing antibody COR-101, for the treatment of hospitalized COVID–19 patients with moderate to severe symptoms, is in Phase Ib/II clinical trials....'By acquiring the equity investment in CORAT we are not only providing the funds needed to accelerate the development process, but also our expertise in manufacturing antibody drugs,'..."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Covid-19 antibody agent COR-101: Heart Foundation welcomes first tests on patients [Google translation] (IDW News) - "The antibody agent COR-101 against Covid-19 has been tested on hospitalized patients suffering from Covid-19 since April 21, 2021. This was announced by the Tübingen University Hospital, which is coordinating the clinical study....'We congratulate the CORAT researchers on this important step in testing the antibody drug on the first Covid-19 patients,' emphasizes Prof. Dr. med. Dietrich Andresen, chairman of the board of the German Heart Foundation."

Trial status • Infectious Disease • Novel Coronavirus Disease

Braunschweig COVID drug: Financing is becoming a brake [Google translation] (Regional Heute) - "In mid-April there was the first funding program with a recommendation for the Braunschweig drug COR-101, now a second funding program has been launched....'Next week we will conclude another private financing round, again with the help of N-Bank and private investors. In addition, we have a positive recommendation from the BMBF to join the first funding program with a Funding volume of 50 million euros. Together with the current financing round, we will have enough financial leeway to complete clinical phase Ib, produce the drug for phase II and carry out phase II in up to 15 study centers across Europe. We hope to have the results of the clinical phase II this year at the latest in the first quarter of 2022 in order to obtain conditional approval...'"

Financing • P2 data • Infectious Disease • Novel Coronavirus Disease

Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19 (clinicaltrials.gov) - P1/2; N=45; Recruiting; Sponsor: Corat Therapeutics Gmbh; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Corona drug: German company is on the verge of a breakthrough [Google translation] (Frankfurter Rundschau) - "The Braunschweig company Corat Therapeutics is currently researching such a drug....If the clinical study is successful, COR-101 should be able to help moderately to seriously ill corona patients....André Frenzel from Corat Therapeutics is of the opinion that the company could apply for emergency approval at the end of 2021."

Regulatory • Infectious Disease • Novel Coronavirus Disease

First hospitalized COVID-19 patient treated with the antibody drug candidate COR-101 (PRNewswire) - "CORAT Therapeutics GmbH announced the start of a clinical trial with COR-101 for treatment of COVID-19 in hospitalized patients....Yesterday, the first patient was treated at the University Hospital of Tuebingen...The phase Ib/II trial...is designed to evaluate the safety and tolerability, as well as the efficacy of COR-101 in hospitalized patients....Results from the first phase of testing are expected in a few months."

Trial status • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] Novel Anti-SARS-CoV2 Antibody Therapy with Safety Design for Treatment of Moderate to Severe COVID-19 (PEGS 2021) - "COR-101 shows potent virus neutralization as well as resistance to known virus mutations. COR-101 is currently investigated in a phase 1b trial of patients with moderate to severe COVID-19."

Clinical • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Novel COVID antibody enters clinical testing (European Biotechnology News) - "German CORAT Therapeutics GmbH got the greenlight for Phase Ib/II testing of COR-101...According to the company, the antibody binds to many mutated variants of SARS-CoV-2, such as the British variant, B.1.1.7., but also to the new and rapidly spreading 'Czech' (N439K) or 'New York' and 'Nigeria' variants (E484K)....The study...is a randomized, double-blind, placebo-controlled, parallelgroup, first-in-human, phase Ib/II study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of COR-101 in hospitalized patients with moderate to severe COVID-19."

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Study to test COR-101 in hospitalized patients with moderate to severe Covid-19 (clinicaltrialsregister.eu) - P1/2; N=261; Ongoing; Sponsor: CORAT Therapeutics GmbH

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19 (clinicaltrials.gov) - P1/2; N=45; Not yet recruiting; Sponsor: Corat Therapeutics Gmbh

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease