Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAT-354 · 2 trials · 2 indications
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg | EXPERIMENTAL | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 300 mg | EXPERIMENTAL | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 600 mg | EXPERIMENTAL | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg (intravenous) | EXPERIMENTAL | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| CAT-354 150 mg (subcutaneous) | EXPERIMENTAL | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
| CAT-354 300 mg (subcutaneous) | EXPERIMENTAL | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg | BIOLOGICAL | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 300 mg | BIOLOGICAL | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 600 mg | BIOLOGICAL | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg (intravenous) | BIOLOGICAL | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| CAT-354 150 mg (subcutaneous) | BIOLOGICAL | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
| CAT-354 300 mg (subcutaneous) | BIOLOGICAL | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
Inclusion Criteria: * Male or female subjects * Age 18 to 65 years at the time of Screening * Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2) * Written informed consent obtained from the subject prior to performing any protocol related procedures, in...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
CAT-354 is an investigational monoclonal antibody being developed for the treatment of asthma. It has been studied in adults with asthma in Phase 2 clinical development. CAT-354 is not approved for commercial use and remains under clinical investigation by AstraZeneca PLC.
CAT-354 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trials evaluating CAT-354 in asthma, including a Phase 2 safety and efficacy study and a Phase 1 bioavailability and pharmacokinetics study.
CAT-354 is in Phase 2 clinical development for asthma. Two trials have been completed: a Phase 2 safety and efficacy study and a Phase 1 bioavailability and pharmacokinetics study. No trials are currently active, and CAT-354 is not FDA approved.
CAT-354 has been evaluated in two completed clinical trials. NCT00873860 was a Phase 2 study of safety and efficacy in 357 adults with asthma across Bulgaria, Germany, Poland, Romania, and the United Kingdom. NCT00638989 was a Phase 1 bioavailability and pharmacokinetics study in 30 healthy male participants in the United States.