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Immune Modulator CYT003 Fails Asthma Study
A phase IIb study of the immune modulator CYT003 in patients with moderate-to-severe allergic asthma has failed to achieve a statistically significant reduction of the Asthma Control Questionnaire (ACQ) score at week 12 in the target patient population compared with placebo.
Additional endpoints, including lung function, also failed to show a statistically significant difference between CYT003 and placebo.
The clinical study was planned to continue with a blinded observation period of 9 months. Considering the negative outcomes, however, the decision was made to unblind and terminate the study.
The results from this trial will be presented at the American Thoracic Society meeting, to be held May 16–21 in San Diego, California.
CYT003 is a first-in-class immune modulator in phase II clinical development as a potential treatment for asthma. The drug inhibits the immune response that causes asthma and was therefore believed be beneficial for control of the disease. In a phase IIa study, CYT003 was shown to maintain asthma control and lung function in patients with persistent allergic asthma, despite the withdrawal of standard therapy with inhaled corticosteroids. Moreover, CYT003 was shown to have a good safety and tolerability profile in more than 450 individuals receiving the active agent.
As a result of the failure to achieve the new study’s primary endpoint, the developer of CYT003 (Cytos Biotechnology) considers the prospects of raising sufficient funding to continue as a going concern to be remote. Consequently, the company’s board of directors has instructed management to evaluate the options for an ordinary winding down of operations and liquidation of the company or a possible bankruptcy.