Additional information: Cyxone to explore options for faster market approval
Due to the interview conducted with Cyxone's CEO by BioStock/Monocl on Thursday, September 28, the company wishes to clarify references made about the extent to which two Phase 2 trials may be equated with a Phase 3 trial.
The regulatory framework relating to drug trials exists to ensure that development companies present significant and reproducable results involving candidate substances so that effectiveness and safety are established using the best scientifc methods prior to a company being able to market a product.
In certain cases it is possible that if two or more Phase 2 trials are conducted in the same way, the results from two trials may be considered as a single trial in statistical terms. It is the responsibiltiy of drug agencies to evaluate whether this can be permitted.
If drug agencies deem the combined analysis of several trials to be the equivalent of a larger follow-up trial, (so called Phase 3), and that the results are sufficiently strong to justify this, this may constitute sufficient grounds to submit an application to authorities responsible for marketing rights.
In the interview with BioStock/Monocl, Cyxone's CEO said that it was possible that Rabeximod may fall into this category, and that Cyxone intends to establish a dialogue with drug agencies at a later date. Prior to that, the company needs to conduct a six-month toxicity study followed by a new Phase 2 trial.
October 5, 2017
This is information that Cyxone AB is required to publish under the EU Market Abuse Directive. The information was provided under the auspices of the above contact person for publication on October 3, 2017 at 11:55 CET. Press release Cyxone AB (publ) 559020-5471 October 5, 2017
Cyxone AB (publ.) is a biopharmaceutical company that develops drugs based on cyclotides, a class of natural plant protein. Cyclotide technology has the potential to provide new drugs with beneficial pharmacological effects on diseases that currently lack safe and effective treatments. The company is focusing on the development of substances that inhibit key processes in cells that are typically associated with various immune disorders, such as multiple sclerosis and rheumatoid arthritis. Cyxone's Certified Adviser on the Nasdaq First North is Erik Penser Bank, which can be reached on +46 (0) 8 46 38 000. www.cyxone.com