Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TEZ · 5 trials · 1 indication
LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
| Arm | Type | Description |
|---|---|---|
| Placebo | OTHER | Participants with genotype F/F received placebo matched to TEZ/IVA fixed dose combination (FDC) in the morning and placebo matched to IVA in the evening for 8 weeks. |
| TEZ/IVA | EXPERIMENTAL | Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks. |
| Ivacaftor | EXPERIMENTAL | Participants with genotype F/RF received placebo matched to TEZ/IVA FDC in the morning and IVA in morning and evening for 8 weeks. |
| Part A | EXPERIMENTAL | Participants weighing \<25 kg received TEZ 50 mg once daily/IVA 75 mg q12h orally for 14 days. Participants weighing ≥25 kg received TEZ 50 mg once daily/IVA 150 mg q12h orally for 14 days. |
| Part B | EXPERIMENTAL | Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg as fixed dose combination orally once daily in the morning and IVA 75 mg orally once daily in the evening for 24 weeks. Participants weighing ≥40 kg received TEZ 100 mg/IVA 150 mg as fixed dose combination orally once daily in the morning and IVA 150 mg orally once daily in the evening for 24 weeks. |
| Part 1: Placebo - Cohort 1A and 1B Combined | PLACEBO_COMPARATOR | Participants received placebo matched to VX-440/TEZ/IVA as triple combination for 4 weeks. |
| Part 1 Cohort 1A: Triple Combination (TC) | EXPERIMENTAL | Participants received VX-440 200 milligram (mg) every 12 hours (q12h)/TEZ 100 mg once daily (qd)/IVA 150 mg q12h as triple combination for 4 weeks. |
| Part 1 Cohort 1B: TC Low Dose | EXPERIMENTAL | Participants received VX-440 200 mg q12h/TEZ 50 mg q12h/IVA 150 mg q12h as triple combination for 4 weeks. |
| Part 1 Cohort 1B: TC High Dose | EXPERIMENTAL | Participants received VX-440 600 mg q12h/TEZ 50 mg q12h/IVA 300 mg q12h as triple combination for 4 weeks. |
| Part 2: TEZ/IVA | ACTIVE_COMPARATOR | Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received placebo matched to VX-440 and TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period. |
| Part 2: TC-2 | EXPERIMENTAL | Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received VX-440 600 mg q12h/ TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period. |
| Name | Type | Description |
|---|---|---|
| TEZ/IVA | DRUG | Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet. |
| IVA | DRUG | Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet. |
| Placebo | DRUG | Placebo matched to TEZ/IVA FDC |
| TEZ | DRUG | - |
| VX-440 | DRUG | - |
| Matched Placebo | DRUG | - |
Key Inclusion Criteria: * Homozygous for F508del or heterozygous for F508del and an RF mutation (as defined in the protocol). * Participants with ppFEV1 of ≥70 percentage points adjusted for age, sex, height. * Participants with a screening LCI2.5 result ≥7.5. * Participants who are able to swallow...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
TEZ is an investigational small molecule being developed for the treatment of Cystic Fibrosis. It is studied in combination with other therapies, such as ivacaftor, in patients with specific CFTR mutations, including the F508del-CFTR mutation. The drug is currently in Phase 3 clinical development.
TEZ is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker VRTX. Vertex is conducting clinical trials to evaluate the safety and efficacy of TEZ in combination with other cystic fibrosis treatments.
TEZ is in Phase 3 clinical development for Cystic Fibrosis. It is an investigational drug and has not been approved by regulatory authorities. Vertex has completed multiple Phase 3 trials evaluating TEZ in combination with ivacaftor in patients with CFTR mutations.
TEZ has been studied in several completed clinical trials, including NCT02565914, a Phase 3 study of VX-661 (tezacaftor) with ivacaftor in patients with F508del-CFTR mutation, and NCT03537651, a Phase 3 long-term safety study of TEZ/IVA. Other trials include NCT02951182 and NCT02953314.
Yes, TEZ is also known as VX-661. Clinical trials such as NCT02565914 and NCT02953314 refer to the drug as VX-661, while later studies like NCT03537651 use the abbreviation TEZ. Both names refer to the same investigational compound developed by Vertex Pharmaceuticals.
TEZ is a small molecule that targets the cystic fibrosis transmembrane conductance regulator (CFTR) protein. It is designed to correct the defective CFTR protein caused by mutations like F508del, improving its function and helping to restore chloride transport in patients with Cystic Fibrosis.