Cypress Bioscience Inc. announced today that results of recently completed Phase IIa trials do not support continuing a development program evaluating combinations of mirtazapine with another approved drug as potential pharmaceutical treatments for obstructive sleep apnea (OSA).
Cypress and Organon, the human healthcare business unit of Akzo Nobel, had each independently conducted Phase IIa trials that served as the basis for today's announcement. A previous independently conducted small preliminary investigator sponsored pilot trial found that mirtazapine was able to reduce the number of abnormal respiratory events over the course of the night by roughly fifty percent. However, those data were not replicated in the recently completed phase IIa trials.
The companies are mutually exploring new potential opportunities to continue the collaboration.
About Cypress Bioscience, Inc.
Cypress is committed to be the innovator and leader in providing products that improve the treatment of Functional Somatic Syndromes, including Fibromyalgia Syndrome (FMS), and other central nervous system conditions. Cypress' strategy involves acquiring/in-licensing undervalued central nervous system active compounds and developing them for new indications.
For more information about Cypress, please visit the Company's web site at www.cypressbio.com.
This press release, as well as Cypress' SEC filings and web site at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat FMS and other related Functional Somatic Syndromes, any potential new collaboration with Organon and any new potential strategic transaction. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress Annual Report on Form 10-K, the most recent Form 10-Q and any subsequent SEC filings. In addition, there is the risk that because we did not achieve statistical significance on our primary endpoints for the first Phase III clinical trial evaluating milnacipran for FMS, that the FDA may not accept the first completed Phase III trial as one of the two pivotal trials required for NDA approval even if we do decide to submit it as such; that upon further analysis of our first Phase III clinical trial, that we and Forest may elect not to continue development of milnacipran; that the results from our second and/or third Phase III clinical trial may not achieve statistical significance, and that we may not be able to protect our milnacipran related patents and proprietary technology. Further, there is a risk that we may not be able to continue our collaboration with Organon and that we may not be successful in identifying, acquiring, licensing and developing any additional product candidates or technologies or integrating any new companies. Cypress undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
For more information, please contact:
For Cypress Bioscience:
Sabrina Martucci Johnson
Chief Financial Officer
Tel. +1 (858) 452-2323