Cytos’ CYT003 Fails to Achieve Clinical Trial Endpoint
Cytos Biotechnology yesterday announced that their Phase IIb clinical study of CYT003 failed to meet its primary or secondary endpoints.
The clinical trial tested patients with moderate to severe allergic asthma, and showed that the immune modulator did not achieve a statistically significant reduction of the Asthma Control Questionnaire (ACQ) score at week 12 in comparison to placebo.
Cytos has consequently decided to unblind and terminate the clinical study, rather than pursue their previous plan to continue with a blinded observation period for 9 months.
As a result of the clinical trial failure for the asthma drug, the condition for the conversion of convertible loan notes has not been achieved. Cytos therefore commented that they view “the prospects of raising new funding sufficient to continue as a going concern to be remote.” The company’s management therefore now evaluating the options “for an ordinary winding down of operations and liquidation of the company or a possible bankruptcy.”
Cytos has also commenced the consultation process for a “mass dismissal” of all of their 36 employees.
Cytos’ Chairman and CEO, Dr. Christian Itin, noted: “we are very disappointed with the outcome of the Phase 2b study and would like to thank our patients and investigators for their support of the study. We would also like to thank our employees for their outstanding effort that was required to rebuild the company after the restructuring and mass dismissals in 2012.”
The company has 31 million Swiss francs in cash, but Cytos have confirmed that they do not expect to be able to repay any bonds or make a liquidation dividend to shareholders.