Aradigm Corp. has completed an independent third-party evaluation of two phase 3 studies for its respiratory disease drug Apulmiq as requested by the U.S. Food and Drug Administration.
Hayward, Calif.-based Aradigm is seeking approval for Apulmiq, known in the EU as Linhaliq, for treating non-cystic fibrosis bronchiectasis, or NCFBE, patients with chronic lung pseudomonas aeruginosa infections. NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. Pseudomonas aeruginosa is a bacterium that can cause disease in plants and animals, including humans.
The FDA has already reviewed Apulmiq once, but ultimately rejected Aradigm's application in January 2018 after errors were discovered in data provided by a contract research organization relating to the safety and efficacy of the medicine. The agency's Antimicrobial Drugs Advisory Committee said it could not approve the drug, which is an inhalable formulation of ciprofloxacin, without a verification of the safety data from an independent third party.
In a Jan. 16 press release, Aradigm said the third-party review has been completed, and it confirmed the treatment effects seen by patients treated with Apulmiq and the main goals of the phase 3 clinical trials that support the FDA application. The new report confirmed that patients experienced a longer time between treatment and when their symptoms became worse — 231 days compared to 158 days to those given placebo. The patients on Apulmiq also showed a statistically significant reduction in the frequency of symptoms returning and severe events in comparison to placebo.
Aradigm has scheduled a meeting with the FDA for Jan. 25 to further discuss the report and resubmission of Apulmiq's new drug application. The company, which focuses on developing and commercializing therapies for respiratory diseases, is also addressing other issues the FDA identified, and a report has been submitted to the regulator for review.
There is no approved treatment to prevent or reduce NCFBE symptoms in patients with chronic lung pseudomonas aeruginosa infection. More than 150,000 people in the U.S. and over 200,000 people in Europe are affected by NCFBE, Aradigm said in the news release.