pp-167 Capsules
Dossier type
CTD
Dossier status
Under development
Country of origin
Israel
GMP approvals
Israel
Comments
Indication: Pulmonary Mycobacterium avium complex (MAC) disease — adults with treatment-naive or relapsed/refractory infection
Clinical stage: Phase 3 — PRIMARY study ongoing
Modality: Small molecule (fixed-dose combination of rifabutin + clarithromycin + clofazimine)
Mechanism / Target: Three-drug synergistic regimen targeting MAC cell wall (rifabutin), protein synthesis (clarithromycin) and membrane integrity (clofazimine); FDC improves adherence vs separate pills
Route / form: Oral fixed-dose combination capsule
Differentiation: Novel FDC simplifies complex MAC regimen (currently 3-4 separate drugs); may improve adherence and outcomes vs current standard of care; addresses growing NTM public health concern
Manufacturer #39192
Specialty pharmaceutical company developing treatments for gastrointestinal and infectious diseases. Advances novel combination regimens for hard-to-treat bacterial infections and GI conditions. Wholly owned pipeline with Phase 3 assets in NTM lung disease.
None