Potential Follow-on Indication for Non-CF Bronchiectasis Patients with Pseudomonas Lung Infections
- Chronic inflammation-infection cycle
- No approved antibiotics
- More than 250,000 patients in the US (2008)1
- 30% of non-CF bronchiectasis patients are infected with Pseudomonas2
We believe we can efficiently develop ARIKACE for these patients:
- Same formulation
- Same delivery technology
- Same safety platform
- Same regulatory processes
Clinical and Regulatory Status
No antibiotics have been approved for this indication. ARIKACE has been granted Orphan Drug status in the US for the treatment of bronchiectasis in patients with Pseudomonas or other susceptible pathogens.
We have reported favorable results from our Phase 2 study (TR02-107) ARIKACE randomized, placebo-controlled phase 2 clinical study results in which the drug was administered once daily for 28 days demonstrated an improvement in time to pulmonary exacerbations/reduced need for anti-Pseudomonas rescue treatment, a decrease in Pseudomonas Log CFUs and a decrease in frequency of cough with expectoration. The study also revealed that ARIKACE was well tolerated with adverse events consistent with underlying chronic lung disease in bronchiectasis patients. Patients in the 560 mg cohort had a slightly higher frequency of dry cough than those in the 280 mg cohort, but the cough was of short duration, was self-limiting, and did not result in any physician choosing to discontinue a patient from the study. Additional details are available here.
1 SDI Innovations in Healthcare Analytics, 2008.
2 Wilson, C.B., et al., Effect of sputum bacteriology on the quality of life of patients with bronchiectasis. Eur Respir J, 1997. 10(8): p. 1754-60; Nicotra, M.B., et al., Clinical pathophysiologic and microbiologic characterization of bronchiectasis in an aging cohort. Chest. 1995. 108(4): p. 955-61.