Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TIP · 1 trial · 1 indication
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Change was determined using the formula = (Post-baseline value - baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Only values for all morphotypes presented.
| Arm | Type | Description |
|---|---|---|
| Cohort A (3 capsules o.d.): TIP | EXPERIMENTAL | Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) |
| Cohort A (3 capsules o.d.): TIP/PBO | EXPERIMENTAL | Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical |
| Cohort A (3 capsules o.d.): PBO | PLACEBO_COMPARATOR | Cohort A (3 capsules o.d.): Inhaled placebo (PBO) |
| Cohort B (5 capsules o.d.): TIP | EXPERIMENTAL | Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) |
| Cohort B (5 capsules o.d.): TIP/PBO | EXPERIMENTAL | Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical |
| Cohort B (5 capsules o.d.): PBO | PLACEBO_COMPARATOR | Cohort B (5 capsules o.d.): inhaled placebo (PBO) |
| Cohort C (4 capsules b.i.d.): TIP | EXPERIMENTAL | Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) |
| Cohort C (4 capsules b.i.d.): TIP/PBO | EXPERIMENTAL | Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical |
| Cohort C (4 capsules b.i.d.): PBO | PLACEBO_COMPARATOR | Cohort C (4 capsules b.i.d.): inhaled placebo (PBO) |
| Name | Type | Description |
|---|---|---|
| TIP | DRUG | TIP dose regimen |
| TIP and placebo | DRUG | TIP and inhaled placebo dose regimen |
| Placebo | DRUG | Inhaled placebo dose regimen |
Key Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed. * Male and female patients of ≥ 18 years of age at screening (Visit 1). * Proven diagnosis of non-CF BE as documented by computed tomography or high-resolution computed tomography * At least 2 or...
TIP is an investigational small molecule being developed for non-cystic fibrosis bronchiectasis, a chronic lung condition. It is designed to treat patients with pulmonary Pseudomonas aeruginosa infection. TIP is currently in clinical development and has not been approved by regulatory authorities.
TIP is a small molecule therapy intended to address pulmonary Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis. Its specific molecular target is not disclosed in available information, but it is being studied for its efficacy in reducing bacterial burden in the lungs.
TIP is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of TIP for non-cystic fibrosis bronchiectasis.
TIP is in Phase 2 clinical development. A Phase 2 dose-finding study has been completed, evaluating the efficacy, safety, and tolerability of TIP in patients with non-cystic fibrosis bronchiectasis and pulmonary P. aeruginosa infection. The drug remains investigational.
TIP has one completed Phase 2 clinical trial, identified as NCT02712983. This randomized, double-blind, placebo-controlled study enrolled 107 participants across Belgium, France, Germany, Italy, Spain, and the United Kingdom. The trial assessed efficacy, safety, and tolerability in adults with non-cystic fibrosis bronchiectasis and P. aeruginosa infection.
TIP is a code name for tobramycin inhalation powder, a formulation of the antibiotic tobramycin. The clinical trial NCT02712983 specifically evaluated this inhaled powder in patients with non-cystic fibrosis bronchiectasis and pulmonary P. aeruginosa infection.