HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (Nasdaq: ARDM) ("Aradigm" or the "Company") today announced results of a third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq.
Aradigm received a Complete Response Letter (CRL) on 26 January 2018, from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Apulmiq as a treatment for non-cystic fibrosis bronchiectasis patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa). The CRL identified issues related to a manual re-review of patient-level pulmonary exacerbation (PE) data conducted by Aradigm after errors were discovered in the analyses performed by a contract research organization. The CRL stated that an independent third party would need to verify the results of the ORBIT-3 and ORBIT-4 Phase 3 trials before the FDA could draw any conclusions regarding the safety and efficacy of Apulmiq from these trials.
Aradigm believes that the results of the TPE verify the significant treatment effects of Apulmiq in ORBIT-4 for the primary endpoint of prolongation of the time to first PE and the secondary endpoints of frequency for all PEs and for severe PEs, as previously reported in the NDA submitted on 26 July 2017. The TPE results also verify the already reported non-significant primary and secondary PE endpoint results of ORBIT-3. These endpoints were all specified in the original statistical analysis plan (SAP) which was reviewed and agreed by FDA. A meeting has been scheduled with the FDA to discuss these Phase 3 trial results now that the TPE has been conducted.
In addition, Aradigm recently received a letter from the FDA Division of Clinical Compliance Evaluation on 27 November 2018 regarding the outcome of an FDA Inspection of Aradigm in January 2018 to audit the conduct of the Phase 3 trials, the unplanned manual re-review of patient-level PE data and the re-adjudication process by Aradigm. The letter concluded that there were no objectionable conditions or practices identified that would justify enforcement action, and no Form 483 was issued.
Aradigm remains confident in the efficacy, safety and quality of Apulmiq. We are committed to continue working toward the approval of Apulmiq for NCFBE patients who have chronic infection with P. aeruginosa, resulting in severe disease with frequent PEs, high morbidity and mortality, and no available treatment options.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm is currently in Phase 3 development of Apulmiq (an investigational proprietary liposomal formulation of ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis. Aradigm's inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.
About Non-Cystic Fibrosis Bronchiectasis
Non-Cystic Fibrosis Bronchiectasis (NCFBE) is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.
More information about Aradigm can be found at www.aradigm.com.
Aradigm, Apulmiq and the Aradigm Logo are registered trademarks of Aradigm Corporation.