STOCKHOLM, Nov. 21, 2019 /PRNewswire/ -- Cyxone (publ), a Swedish biotech in autoimmune diseases, announced today that the company has signed an agreement with a UK contract research organization (CRO) to conduct the six-month toxicology studies with Rabeximod as required ahead of the Phase IIb study. Preparations for the toxicology studies began immediately with a plan of initiating the studies directly thereafter.
Malin Berthold, Head of Project Management at Cyxone, comments "After thorough evaluation, we were able to decide upon this CRO as our partner of choice for these preclinical studies. The selected CRO has an excellent reputation and we got a great impression of their quality and professionalism from the start. We now look forward to take the next step in the development program for our Phase II candidate Rabeximod."
The planned clinical phase IIb trial is a multi-center, randomized, double-blind, placebo-controlled, where patients with moderate to severe RA, who have previously been treated with methotrexate with inadequate response, will be treated 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. Before patients are treated with Rabeximod for 24 weeks, Cyxone must conduct additional preclinical toxicology studies with the substance to confirm its safety for 24 weeks of treatment. Safety data for 12 weeks of treatment with Rabeximod already exist. The additional toxicology studies are scheduled to be initiated during 2019.
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