Cyxone assigns Aptuit for the capsulation of Phase II candidate Rabeximod
Cyxone (publ), a Swedish biotech in autoimmune diseases, announced today that the company has signed an agreement with Aptuit, an Evotec company, to perform the capsulation of the Rabeximod substance. This is a key step in the preparation of the planned Phase IIb study, in which patients will be administered capsules with Rabeximod, therefore securing a further step in the Rabeximod Phase IIb program.
Malin Berthold, Head of Project Management at Cyxone, comments “We are glad to enter this partnership with Aptuit. They were responsible for the successful capsulation for the previous 12-week Phase II study conducted by OxyPharma, and we feel confident in selecting this partner again. Securing this agreement marks a further step in the Rabeximod Phase IIb program.”
The Rabeximod substance to be used in the planned Phase IIb study is already manufactured according to the appropriate GMP requirements. Aptuit will formulate the Rabeximod substance from its current granulated form to capsules for administration to patients. This process includes a number of studies and tests to ensure fulfilled quality, validation and safety regulatory requirements.
The work with Aptuit is planned to be initiated early next year. The planned clinical phase IIb trial is a multi-center, randomized, double-blind, placebo-controlled study, in which patients with moderate to severe RA, who are on a steady dose of methotrexate will be treated also with Rabeximod for 24 weeks. The aim of the Phase IIb study is to confirm Rabeximod’s therapeutic effect as well as good safety and tolerability.
Contact
Ola Skanung, CFO and interim CEO
Phone: +46 (0) 705 121 040
Email: ola.skanung@cyxone.com
Cyxone AB (publ)
Adelgatan 21
211 22 Malmö, Sweden
About Cyxone
Cyxone AB is a clinical stage biotech company with a portfolio of immunomodulating drugs for the treatment of autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis (RA). The company’s drug portfolio is based on two technological pillars in the form of oral molecules and cyclotide-based drugs that inhibit key processes in the body’s cells that are typically associated with various immune-related disorders. Cyxone’s technologies have the potential to address an unmet need and provide new effective and safe medicines that can improve the quality of life for patients affected by autoimmune diseases. The company has two drug candidates, T20K for MS in clinical phase I program and Rabeximod for RA in clinical phase II program. Cyxone’s Certified Adviser on the Nasdaq First North Growth Market is Mangold Fondkommission AB, +46 (0)8-503 015 50, ca@mangold.se. www.cyxone.com
About Evotec SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 2,900 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases and fibrosis. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Celgene, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.