Date: 2014-04-14
Type of information:
phase: 2b
Announcement: results
Company: Cytos Biotechnology (Switzerland)
Product: CYT003
Action
mechanism: CYT003 is a novel allergen-independent immunotherapy with disease-modifying potential that could be used to treat a broad range of different allergies. In a successfully completed Phase 2a study, this TLR9-agonist was shown to maintain asthma control and lung function and asthma control in patients with persistent allergic asthma, even as standard inhaled corticosteroid treatment was withdrawn. CYT003 has been shown to be safe in over 450 patients to date.
Disease: allergic asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: Europe (Hungary), USA
Trial
details: The study is a randomized, placebo-controlled, phase IIb dose-finding study of CYT003-QbG10, a TLR9-Agonist, in patients with moderate to severe allergic asthma not sufficiently controlled on current standard therapy (GINA Steps 3+4). The purpose of this study is to assess the therapeutic potential and safety/tolerability of QbG10 at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy. Altogether 360 patients randomized to 4 treatment groups will be included. The study compares three dose strength with placebo. Each patient receives 7 injections of study drug or undistinguishable placebo. Key outcome measures are patient reported parameters on their asthma. (NCT01673672 and EUDRA-CT number 2012-003070-39)
Latest
news: * On April 14, 2014, Cytos Biotechnology has announced that the Phase 2b study of CYT003 in patients with moderate to severe allergic asthma did not achieve a statistically significant reduction of the Asthma Control Questionnaire (ACQ) score at week 12 in the target patient population compared to placebo. Patients on placebo and at all dose levels of CYT003 achieved a clinically relevant improvement in their asthma control measured by ACQ. Additional endpoints, including lung function also failed to show a statistically significant difference to placebo. The clinical study was planned to continue with a blinded observation period of 9 months. Considering the clear outcome, Cytos has determined to unblind and terminate the clinical study. As a result of the failure to achieve the primary endpoint, the previously announced condition for the conversion of convertible loan notes has not been achieved, and the company therefore considers the prospects of raising new funding sufficient 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. In addition, the company has initiated the consultation process for a mass dismissal of all of the company’s 36 employees. The cash balance of the company as of March 31st, 2014 was CHF31 million. The company does not expect to be able to repay any convertible bonds which are all subordinated to other creditors. Likewise, the company also does not expect to be able to pay any liquidation dividend to shareholders. Results of the Phase 2b study will be presented at the American Thoracic Society meeting, May 16-21, 2014 in San Diego, USA. * On October 21, 2013, Cytos Biotechnology has announced that patient enrolment has been completed in the on-going phase 2b study with its lead product CYT003. This study investigates the effectiveness, safety and tolerability of CYT003 in patients with moderate to severe allergic asthma not controlled on their standard treatment. Based on the completion of the enrolment of this study, Cytos will call the second tranche of the convertible loan notes in the amount of CHF 6.625 million from Abingworth, venBio, Aisling and Amgen, which was part of the investment by this syndicate of investors in May 2012. Topline data from the study are expected in the second quarter of 2014. * On January 16, 2013, Cytos has provided an update of Phase 2b clinical trial of CYT003 in allergic asthma. In the course of periodic drug quality measurements, a technical issue was identified with the rubber stoppers used to close the injection vials containing the clinical trial material. Cytos will replace this clinical trial material and have new material available at clinical trial sites in Q2 2013.The clinical trial will recruit approximately 360 adult patients with moderate to severe allergic asthma not sufficiently controlled on current standard therapy. The study will be conducted at more than 90 centers in North America and Europe, and is expected to read out top-line data in 1H 2014. Regulatory approvals to conduct the trial have been obtained in various countries in Europe and North America including the United States, where an IND (Investigational New Drug) application has been approved by the FDA.
