Cyxone, a biotech company specializing in autoimmune diseases, in collaboration with its CDMO partner, has streamlined part of the manufacturing process for its drug candidate Rabeximod, which is under development for the treatment of rheumatoid arthritis (RA).
Cyxone AB (publ) hereby announces that the members of the nomination committee have been appointed ahead of the 2023 AGM. The nomination committee has been appointed in accordance with the guidelines laid down at the 2022 AGM
Cyxone AB (publ) announces today that the company is expecting to communicate top-line results from a recently concluded Phase 2 trial of its drug candidate Rabeximod in Covid-19 patients during the fourth quarter. The results were previously slated for the third quarter. The postponement is due to the company’s decision to leverage the U.S. Food and Drug Administration (FDA) initiative to pre-review the statistical analysis plan for the clinical trial, whereby the exact timing of the results will depend on the process and discussion required with the FDA. This is an extraordinary opportunity provided by the authority to expedite the development of safe and efficacious Covid-19 treatments.
After identifying some valuable new potential treatments for T20K, Cyxone AB (publ) (“Cyxone or the Company”) today announced that the company has entered into a research collaboration with Prof. Christian Gruber, the inventor of T20K & Prof. Gernot Schabbauer from the Medical University of Vienna. The aim of the study is to deepen the understanding of the mode of action (MoA) of T20K and to explore these new uses and the potential to provide significant additional therapeutic benefit in a model for multiple sclerosis. The study will start later this month, with planned readout in June 2022, and constitutes studies required for approval to test in humans with the new administration form.
Cyxone announced today the initiation of key preclinical studies required to enable taking Multiple Sclerosis drug candidate T20K forward. Firstly, the company will select a Contract Manufacturing Organization (CMO) to establish a new manufacturing process to produce larger quantities of GMP (Good Manufacturing Practice) grade material needed in further preclinical and clinical studies.
STOCKHOLM, Jan. 15, 2021 /PRNewswire/ -- Cyxone (publ.) announced today that the first patient has been screened in the Phase 2 clinical trial of Rabeximod in Covid-19. The trial will evaluate the efficacy and safety of oral treatment with Rabeximod to prevent disease progression in hospitalized Covid-19 patients and shorten the time to recovery. The study will include 300 patients at clinical centers in Poland, Slovakia and up to three additional countries in Europe. Cyxone expects to announce preliminary results in the third quarter of 2021.
STOCKHOLM, Dec. 15, 2020 /PRNewswire/ -- Cyxone (publ.), a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod. The application follows on a productive pre-IND meeting with the authority, where valuable advice was received on inter alia the protocol for its imminent European Phase 2 clinical study in moderate Covid-19. The IND covers the development of Rabeximod in Covid-19 and other indications, such as rheumatoid arthritis, and is a prerequisite for a future validation of the company's five recent patent applications in the US market.
Cyxone is set to initiate a Phase II clinical trial with Rabeximod in moderate Covid-19 patients after it received approval from the regulatory authority and the ethics committee in Poland.
STOCKHOLM, Dec. 8, 2020 /PRNewswire/ -- Cyxone (publ.) announced today it has received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms (ARDS) caused by virus-related overactivation of the immune system. Preliminary results are expected in the third quarter of 2021.
STOCKHOLM, Nov. 10, 2020 /PRNewswire/ -- Cyxone (publ.) announced today that the company has filed for an extended patent protection of Rabeximod with the European Patent Office (EPO), that will be extended to other territories in due course. An approval of the application will strengthen the company's intellectual property portfolio and generate a longer market exclusivity for Rabeximod.